Ostelin Training Level 2

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Lesley Lawson
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1 Ostelin Training Level 2

2 Objectives At the end of this product training, you should be: Familiar with the importance and benefits of Vitamin D and calcium Aware of conditions relating to Vitamin D deficiency Comfortable with the Ostelin products, their features and benefits

3 Leading Brand Australia s #1 Bone Health and Vitamin D brand * Ostelin is Halal accredited *Aztec scan data, MAT 7/4/2013

4 Vitamin D Sources

5 Sunlight The sun is our major source of obtaining Vitamin D.

6 Vitamin D synthesis UVB nm 6

7 How much sun is needed? Source: 2. Stalgis Bilinski, et al. Burning Daylight: balancing vitamin D requirements with sensible sun exposure. MJA 2011; 194 (7):

Vitamin D levels are reduced in winter Seasonality Women of all ages are at risk of low Vitamin D Serum 25-(OH)D levels are lower in winter when exposure to the sun s UV radiation is reduced.

8 Vitamin D levels are reduced in winter Seasonality Women of all ages are at risk of low Vitamin D Serum 25-(OH)D levels are lower in winter when exposure to the sun s UV radiation is reduced. A Geelong study revealed that during winter: 43% of females had mild Vitamin D deficiency (28-50 nmol/l) 11% of females had moderate/severe Vitamin D deficiency (<28 nmol/l) Pasco JA, et al. Med J Aust 2001;175(8): Cross sectional study of a population based, random sample of 861 women aged years from the Barwon Statistical Division (which includes Geelong) in Victoria. Main outcome measures were Vitamin D intake, serum 25 (OH)D level, season of assessment and exposure to sunshine. May October. Levels <50nmol/L associated with preosteomalacic changes on bone biopsy. Adapted from Pasco JA et al. In Australia, season is more important than latitude in determining vitamin D concentrations

9 Food Sources Very few foods in nature contain vitamin D The flesh of fatty fish and fish liver oils are among the best sources. Small amounts of vitamin D are found in beef liver, cheese, and egg yolks. Fortified foods provide most of the vitamin D in our diet. Food examples include: Fish Liver oil Fatty fish (salmon, tuna, mackerel) Egg yolks Cheese Fortified foods (e.g. some dairy products and spreads)

10 Dietary Intake It is estimated that dietary intake alone may be below an adequate amount 1. Supplementation may be required. 1. Nowson CA, Margerison C. Vitamin D intake and vitamin D status of Australians. Med J Aust 2002;177:149 52

11 Vitamin D Levels & Measurement

12 Optimal Vitamin D Optimal blood levels around 75 nmol/l 4 Recommended Daily Intake Adults require 1,000 IU daily to achieve optimal blood levels if sun exposure is restricted 5 Children under 12 years of age are recommended 200IU per day or 400IU per day if they fall within a high risk group 6 Toxicity There is no evidence of adverse effects at 140 nmol/l, equivalent to a supply of 10,000 IU/day 7 4. Osteoporosis Australia. Calcium, Vitamin D and osteoporosis a guide for GPs. 2nd ed Holick MF. The vitamin D epidemic and its health consequences. JNutr.2005 Nov;135(11):2739S 48S. 6. Munns C, Zacharin MR, Rodda CP,et al. Paediatric Endocrine Group; Paediatric Bone Australasia. Prevention and treatment of infant and childhood vitamin D deficiency in Australia and New Zealand: a consensus statement. Med J Aust. 2006;185(5): Vieth R.Vitamin D supplementation,25 hydroxyvitamin D concentrations, and safety. Am J ClinNutr May;69(5):

13 Vitamin D Levels Vitamin D deficiency is determined by a single measurement of 25 hydroxy vitamin D (via a blood test) Audran M, Briot K. Critical reappraisal of vitamin D deficiency. Joint Bone Spine Jan 22. [Epub ahead of print] 9. ANZ Bone and Mineral Society. "Vitamin D and adult bone health in Australia and New Zealand: a position statement." Med J Aust 2005;182(6):

14 Measuring Vitamin D The only way to determine whether a person is vitamin D sufficient, deficient, or intoxicated is to measure the circulating concentrations of 25 hydroxy vitamin D (25(OH)D) 10 Calcitriol (the hormonally active form of Vitamin D) is not a good indicator of vitamin D status because: Its half life in circulation is less than 4 hrs Its concentrations are approx fold less than 25 hydroxy vitamin D When a person becomes vitamin D deficient and 25 hydroxy vitamin D levels decrease, there is a compensatory increase in parathyroid hormone, which stimulates the kidney to produce more calcitriol (and present in the normal range) 10. Holick MF. Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and for cardiovascular disease. Am J Clin Nutr. 2004; 80 (6) :1678S 88S

15 Vitamin D status has such important health implications that a measurement of 25(OH)D should be part of a routine physical examination for children and adults of all ages. 5. Holick MF. The vitamin D epidemic and its health consequences. J Nutr Nov;135(11):2739S 48S

16 Vitamin D testing Testing for vitamin D has increased more than tenfold in the last five years, faster than any other medical test. 4,500,000 4,032,368 4,000,000 In 2012 there was a 28% increase in testing over 2011 YTD testing to March 2013 reflects 26% growth vs ,659,245 3,139,894 3,500,000 3,000,000 2,500,000 1,849,776 2,000,000 1,154,453 1,057,653 1,500,000 1,000, , , ,301 28,732 46,928 65,352 90, , ,000 0 Dec-00 Dec-01 Dec-02 Dec-03 Dec-04 Dec-05 Dec-06 Dec-07 Dec-08 Dec-09 Dec-10 Dec-11 Dec-12 Mar-13 Medicare tests March 2013

17 At Risk Groups

18 Who is impacted? Low Vitamin D levels are more common than previously thought It s not just the osteoporotic or the elderly. It impacts both men & women and impacts all ages

19 Up to 1 in 3 Australians Up to 1 in 3 Australians * may have low Vitamin D levels * In adults and certain other groups. See for more information

20 Causes of low Vitamin D levels Why? The following factors may interfere with the skin penetration of UVB for the formation of vitamin D: Indoor lifestyle Concealing clothing Age Increased skin melanin pigmentation Sunscreen 9 9. ANZ Bone and Mineral Society. "Vitamin D and adult bone health in Australia and New Zealand: a position statement." Med J Aust 2005;182(6):

Groups most at risk Darker Skin People with naturally darker skin tones as

have darker skin tones or wear concealing clothing for cultural or religious

21 Groups most at risk Darker Skin People with naturally darker skin tones as they require longer UVB exposure times 4 Pregnant women Especially those who have darker skin tones or wear concealing clothing for cultural or religious reasons 4 4. Osteoporosis Australia, Calcium, Vitamin D and Osteoporosis. A Guide for GPs. 2nd Edition, 2008, p1 15 Concealed Clothing Those who wear clothing which covers up the majority of their skin for cultural or religious reasons 4

Groups most at risk Indoor Lifestyle Individuals with limited sun exposure * or institutionalised individuals 4 The elderly A person 70

D stores are sequestered deep in body fat, making it less bioavailable 5 10. Holick MF.

2004; 80 (6) :1678S 88S 4. Osteoporosis Australia, Calcium, Vitamin D and Osteoporosis. A Guide for GPs. 2nd Edition, 2008, p1 15 5.

22 Groups most at risk Indoor Lifestyle Individuals with limited sun exposure * or institutionalised individuals 4 The elderly A person 70 years of age exposed to the same amount of sunlight as a 20 year old will produce up to 75% less vitamin D 10 Overweight or obese Vitamin D stores are sequestered deep in body fat, making it less bioavailable Holick MF. Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and for cardiovascular disease. Am J Clin Nutr. 2004; 80 (6) :1678S 88S 4. Osteoporosis Australia, Calcium, Vitamin D and Osteoporosis. A Guide for GPs. 2nd Edition, 2008, p Holick MF. The vitamin D epidemic & its health consequences J Nutr. 2005; 135: S *. ^Limited sun exposure of less than 2 3 hours per week during winter in southern regions of Australia.

23 Other groups at risk Other at risk groups Infants of mothers who are low in vitamin D 4 Those with malabsorption syndromes eg. IBS 4 People with skin related conditions where avoidance of sunlight is required 4 4. Osteoporosis Australia, Calcium, Vitamin D and Osteoporosis. A Guide for GPs. 2nd Edition, 2008, p1 15

24 Pregnancy

Pregnancy During pregnancy, maternal vitamin D requirements can increase up to 4 or 5 fold to facilitate the availability of extra calcium for foetal skeletal growth 11 Some evidence shows that low

25 Pregnancy During pregnancy, maternal vitamin D requirements can increase up to 4 or 5 fold to facilitate the availability of extra calcium for foetal skeletal growth 11 Some evidence shows that low maternal levels of vitamin D are associated with potential adverse outcomes for both mother and foetus as well as neonate and child 12 Evidence strongly supports testing for Vitamin D deficiency early in pregnancy 13 Lactation Breast milk is a poor source of vitamin D 14 so it is important that maternal vitamin D status is adequate during pregnancy Pregnancy and lactation 11. Lewis S, Lucas RM, Halliday J, Ponsonby AL. Vitamin D deficiency and pregnancy: from preconception to birth. Mol Nutr Food Res Aug;54(8): Barrett H, McElduff A. Vitamin D and pregnancy: An old problem revisited. Best Pract Res Clin Endocrinol Metab Aug;24(4): Ebling. Routing screening for vitamin D deficiency in early pregnancy: past its due date? MJA 194; Pettifor, John M. Nutritional rickets: deficiency of vitamin D, calcium or both?. American Journal of Clinical Nutrition. Vol. 80, No. 6 Supplement (December 2004), pp. 1725S 1729S

26 Incidence of pregnancy deficiency Incidence of vitamin D deficiency in pregnancy in Australia Deficiency defined here as <50nmol/L 6 A population based study of 971 pregnant women 15 and their neonates from south eastern Sydney found that 15% of women were moderately/severely vitamin D deficient and 33% were mildly vitamin D deficient Although immigrant, veiled and dark skinned women are at greatest risk, even in the fairest skinned women, 47% were found to be vitamin D deficient Across the three categories of white skinned women, 31% were deficient. Of the 2 categories of dark skinned women, 74% were deficient. Veiled women were of greatest risk: 71% were found to be moderately/severely deficient 6. Munns C, Zacharin MR, Rodda CP,et al. Paediatric Endocrine Group; Paediatric Bone Australasia. Prevention and treatment of infant and childhood vitamin D deficiency in Australia and New Zealand: a consensus statement. Med J Aust. 2006;185(5): Bowyer L, Catling Paull C, Diamond T, Homer C, Davis G, Craig ME. Vitamin D, PTH and calcium levels in pregnant women and their neonates. Clin Endocrinol (Oxf) Mar;70(3):372 7

27 Children

28 Children Children Vitamin D deficiency and nutritional rickets are re emerging as paediatric health issues in Australia and New Zealand 6 Adequate vitamin D is vital for bone growth, maintenance and development in children Undetected vitamin D deficiency may reduce children from reaching their genetically programmed height and peak bone mass Munns C, Zacharin MR, Rodda CP,et al. Paediatric Endocrine Group; Paediatric Bone Australasia. Prevention and treatment of infant and childhood vitamin D deficiency in Australia and New Zealand: a consensus statement. Med J Aust. 2006;185(5): Holick, M. F. Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and for cardiovascular disease. American Journal of Clinical Nutrition. 2004; 80 (6): 1678S 88S

29 Deficiency causes in kids Causes of low vitamin D in children and adolescents 6 Reduced synthesis or intake Being born to a mother with low vitamin D levels Prolonged breastfeeding Darker skin colour Reduced sun exposure (due to modest clothing, chronic illness or excessive sunscreen use) Low intake of foods containing vitamin D Abnormal gut function or malabsorption Reduced synthesis or increased degradation of vitamin D metabolites (eg. from low liver function or use of certain medication) 6. Munns C, Zacharin MR, Rodda CP,et al. Paediatric Endocrine Group; Paediatric Bone Australasia. Prevention and treatment of infant and childhood vitamin D deficiency in Australia and New Zealand: a consensus statement. Med J Aust. 2006;185(5):268 72

Incidence of deficiency in kids Incidence of vitamin D deficiency in children in Australia and New Zealand In Tasmania, 8% of 8 year old children 6 and 68% of 16 yearold children (who took part in

30 Incidence of deficiency in kids Incidence of vitamin D deficiency in children in Australia and New Zealand In Tasmania, 8% of 8 year old children 6 and 68% of 16 yearold children (who took part in the study) have serum 25 OHD concentrations less than 50 nmol/l (a measurement of deficiency) 6a New Zealand data is comparable, with 50% of children in all age groups with serum 25 OHD levels less than 50nmol/L 6 6. Cited by Munns C, Zacharin MR, Rodda CP,et al. Paediatric Endocrine Group; Paediatric Bone Australasia. Prevention and treatment of infant and childhood vitamin D deficiency in Australia and New Zealand: a consensus statement. Med J Aust. 2006;185(5): a. Jones G, Dwyer T, Hynes KL, et al. Vitamin D insufficiency in adolescent males in Southern Tasmania: prevalence, determinants, and relationship to bone turnover markers. Osteoporos Int 2005; 16:

31 Vitamin D Health Benefits

32 Bone Health

33 Vitamin D for Bone Health Bone health is critically important for overall health and quality of life. Healthy bones provide thebodywithaframethatallowsfor mobility and for protection against injury. Bones serve as a storehouse for minerals that are vital to the functioning of many other life sustaining systems in the body.

34 Skeletal diseases Consequences of vitamin D deficiency Deficiency is recognised in 3 major skeletal diseases Rickets Osteomalacia Osteoporosis Suggested mapping of the principal vitamin D related bone disease onto the serum 25(OH)D3 concentration continuum. (To convert values to nanograms per millilitre, divide values by 2.5.) 16 Vitamin D deficiency has also been associated with a range of other major health outcomes Heaney RP. Functional indices of vitamin D status and ramifications of vitamin D deficiency. Am J Clin Nutr Dec;80(6 Suppl):1706S 9S. 10. Holick MF. Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and for cardiovascular disease. Am J Clin Nutr. 2004; 80 (6) :1678S 88S

35 Bone health: Important for bone health at all stages of life because vitamin D: Is essential for the absorption of calcium and phosphorus from the small intestine Regulates blood levels of calcium Promotes optimal bone mineralisation Bone health requirements Without vitamin D, only 10-15% of dietary calcium and 60% phosphorus is absorbed Holick MF. "Vitamin D Deficiency." The New England Journal of Medicine. 2007;357(3):

36 Osteoporosis

$brittle and are therefore more likely to break so there is an increased risk of fractures. Check with your healthcare professional.$ This happens when bones lose minerals, like calcium, faster than the body can replace them Lack of calcium is the major cause of

This happens when bones lose minerals, like calcium, faster than the body can replace them Lack of calcium is the major cause of

37 Osteoporosis definition Osteoporosis (meaning porous bones) is a condition where bones lose their density, become thin, fragile and brittle and are therefore more likely to break so there is an increased risk of fractures. Check with your healthcare professional. This happens when bones lose minerals, like calcium, faster than the body can replace them Lack of calcium is the major cause of osteoporosis causing a gradual loss of bone mass mainly affecting the spine, hips & ribs Women are at a much greater risk of osteoporosis especially post menopause

$1 in 2 Australian women and 1 in 3 Australian men over 60 years will have a fracture due to osteoporosis. 4 4.$

38 Prevalence in Australia Did you know? 1 in 2 Australian women and 1 in 3 Australian men over 60 years will have a fracture due to osteoporosis Osteoporosis Australia, Calcium, Vitamin D and Osteoporosis. A Guide for GPs. 2nd Edition, 2008, p1 15

39 Risk factors: Osteoporosis risk factors Ageing Menopause oestrogen enhances calcium absorption and maintains bone strength. When oestrogen levels decline at menopause, bone loss accelerates and bones can lose 1 5%of their mineral content each year Family history Low testosterone in men Lifestyle factors sedentary lifestyle, smoking, lack of sunlight exposure Dietary factors high alcohol consumption, inadequate nutritional intake especially low in Calcium and Vitamin D

$Symptoms Osteoporosis usually has no signs or symptoms until a fracture happens this is why osteoporosis is often called the 'silent disease'.$

40 Symptoms Osteoporosis usually has no signs or symptoms until a fracture happens this is why osteoporosis is often called the 'silent disease'. Fractures due to osteoporosis can lead to changes in posture (e.g. developing a stoop or Dowager's hump in your back), muscle weakness, loss of height and bone deformity of the spine. Osteoporosis Australia. About osteoporosis. Available at:

41 The cost on society Osteoporosis poses a significant public health issue In Australia in 2007, someone is admitted to a hospital with an osteoporotic fracture every 5 6 minutes The direct costs associated with these fractures amount to an estimated 1.9 billion dollars each year Approximately 25% of patients over 50 with hip fractures die within 12 months of the fracture 2.2 million Australians have an Osteoporosis related condition this will become 3 million by Osteoporosis Australia, The Burden of Brittle Bones Epidemiology, Costs & Burden of Osteoporosis in Australia. 2007, p1 16

42 Fracture risk reduction Vitamin D reduces facture risk in 2 ways: by decreasing falls and increasing bone density 19 Vitamin D increases the absorption of calcium 19. Bischoff Ferrari, H. (2009). "Vitamin D: what is an adequate vitamin D level and how much supplementation is necessary?" Best Pract Res Clin Rheumatol 23(6):

43 Osteoporosis & Menopause Vitamin D has been shown to reduce falls and fracture risk in older postmenopausal women 20 In women, oestrogen enhances calcium absorption and maintains bone strength. Vitamin D therapy in the older postmenopausal woman can lead to useful reductions in fracture rates and falls, especially in populations with reduced exposure to sunlight, which is potentially the majority of postmenopausal women in both developed and developing countries. 20. Prince RL. Calcium and vitamin D for whom and when. Menopause Int Mar;13(1):35 7

44 Fracture prevention Achieving optimal serum levels in populations could reduce fractures by 50 60% 21 The Osteoporosis Education Project estimates that supplementation with therapeutic levels of vitamin D could result in an overall 50 60% reduction in low trauma osteoporotic fractures. While the factors contributing to fragility fractures are varied, vitamin D deficiency/insufficiency clearly represents a significant factor; it is also an easy factor to correct. For the billion or more people worldwide who are vitamin D deficient/insufficient, achievement of vitamin D sufficiency should be seen as the first line intervention for fracture prevention. 21. Brown SE. Vitamin D and fracture reduction: an evaluation of the existing research. Altern Med Rev Mar;13(1):21 33.

45 Calcium for Osteoporosis Fracture patients were also found to have a low calcium intake More than half of Australian adults do not reach their recommended daily intake of calcium mg dietary intake of calcium a day is recommended for all adults and 1300mg is recommended for women aged over 50 years and men aged over 70 years 4 4. Osteoporosis Australia. Calcium, Vitamin D and osteoporosis a guide for GPs. 2nd ed 2008

Importance of Calcium Calcium is essential for building and maintaining bone. It combines with other minerals to form the hard crystals that give bone its strength.

46 Importance of Calcium Calcium is essential for building and maintaining bone. It combines with other minerals to form the hard crystals that give bone its strength. Almost all the body's calcium (about 99%) is found in the bones and teeth. Our bodies cannot make calcium, so it must come from our diets. When you are not getting sufficient amounts of calcium in your diet, some of the calcium crystals in bone dissolve and give their calcium back to the bloodstream. If your calcium intake is too low and there are more withdrawals than deposits from your calcium bone bank, you risk losing bone strength. In adults, dietary calcium is vital in order to maintain bone strength. As we age calcium is absorbed less effectively from the intestine, so that intake needs to be increased.

47 Calcium & Vitamin D Ameta analysis of trials of calcium for postmenopausal osteoporosis found that calcium supplements reduced bone loss by approximately 2% after two or more years of use and calcium supplements reduced the risk of spinal fractures by about 23% 22 Ameta analysis of trials done by Australian researchers that used calcium or calcium with vitamin D, found that they may assist in the prevention of osteoporosis in people 50 years or older; recommended minimum therapeutic doses were 1200 mg of calcium and 800 IU of vitamin D Shea, B, Wells G, Cranney,et al. Meta Analysis of Calcium Supplementation for the Prevention of Postmenopausal Osteoporosis. Endocr Rev : Tang BM, Eslick GD, Nowson C, et al. Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta analysis.lancet Aug 25;370(9588):

48 Low calcium & fracture rates 22 38% of hip fracture patients had a calcium intake below the recommended minimum of 800 mg/day 24 Image: 22. Shea B, et.al. VII. Meta analysis of calcium supplementation for the prevention of postmenopausal osteoporosis. Endocr Rev Aug;23(4): Cho K, Cederholm T, Lökk J. Calcium intake in elderly patients with hip fractures. Food Nutr Res. 2008;52

49 Combine Calcium and Vitamin D Simultaneous correction is necessary for two reasons: 1. If one is low the other is often low 2. Adequate vitamin D is required to achieve the nutritional benefits of calcium and vice versa 25. Peterlik M, Boonen S, Cross HS, Lamberg Allardt C. Vitamin D and calcium insufficiency related chronic diseases: an emerging world wide public health problem. Int J Environ Res Public Health Oct;6(10):

50 Calcium + Vitamin D Reduce Fracture Risk A meta analysis of trials done by Australian researchers that used calcium or calcium in combination with vitamin D, found that it was effective as a preventive treatment for osteoporosis in people aged 50 years or older and the recommended therapeutic doses were a minimum of 1200 mg of calcium and 800 IU of vitamin D mg/day Calcium or more reduces fracture risk by 20% compared to 6% for less than 1200 mg/day 800 IU/day or more Vitamin D reduces fracture risk by 16% compared to 13% for less than 800 IU/day 24% risk reduction in trials (8 out of 24) with >80% compliance Those with low serum 25(OH)D (<25 nmol/l) had a greater risk reduction 23. Tang BM, Eslick GD, Nowson C, Smith C, Bensoussan A. Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta analysis. Lancet 2007;370(9588):657 66

Weight bearing exercise that includes impact (e.g. walking, jogging or aerobics): 30 minutes, 3 times weekly Adequate calcium intake: 1200 1500 mg/d

51 Weight bearing exercise that includes impact (e.g. walking, jogging or aerobics): 30 minutes, 3 times weekly Adequate calcium intake: mg/d Adequate vitamin D intake: 800 IU/d Smoking cessation Limit alcohol intake Musculoskeletal Health General recommendation for maintenance of musculoskeletal health

52 Muscle Strength

Vitamin D for Muscle Strength Helps maintain muscle strength it maintains calcium supply to muscles for contraction and deficiency may result in muscle weakness and pain Vitamin D is required to

53 Vitamin D for Muscle Strength Helps maintain muscle strength it maintains calcium supply to muscles for contraction and deficiency may result in muscle weakness and pain Vitamin D is required to maintain normal blood levels of calcium and phosphate, which are in turn needed for the normal mineralisation of bone, muscle contraction, nerve conduction, and general cellular function in all cells of the body. May reduce the risk of falls in the elderly as it improves neuromuscular/neuroprotective function Dhesi JK, et al. Vitamin D supplementation improves neuromuscular function in older people who fall. Age Ageing Nov;33(6):

54 Immune Health

Vitamin D for Immune Health Involved in the regulation of the immune system Vitamin D receptors are expressed on most cells of the immune system, including macrophages, and it has been found that, in

55 Vitamin D for Immune Health Involved in the regulation of the immune system Vitamin D receptors are expressed on most cells of the immune system, including macrophages, and it has been found that, in some instances, macrophages can produce the enzyme that converts 25 hydroxyvitamin D to calcitriol (the active hormone form) 27. Macrophages are the body's first line of defence and have many roles. A macrophage is the first cell to recognize and engulf foreign substances (antigens). Macrophages break down these substances and present the smaller proteins to the T lymphocytes. (T cells are programmed to recognize, respond to and remember antigens). 27. Linus Pauling Institute. Vitamin D. (accessed 15/05/11)

56 Vitamin D Function Summary Improves the absorption of dietary calcium May reduce the risk of fractures and falls in the elderly Aids calcium absorption (a diet deficient in calcium can lead to osteoporosis in later life) Supports bone mineral density Helps maintain muscle function and strength Supports immune system function Important throughout pregnancy for the developing baby

57 Safety & Contra Indications

58 Safety Daily Vitamin D, Useful and Safe For chronic supplementation to protect against bone loss, a daily dosage of at least 800 IU seems required. From a public health perspective, supplying at least 800 IU per day seems useful and low risk 8. Toxic effects of vitamin D have only been seen at serum 25(OH)D concentrations well above 200 nmol/l, which requires a daily intake of 40,000 IU. This level is now considered to be the Lowest Observed Adverse Effect Level Audran M, Briot K. Critical reappraisal of vitamin D deficiency. Joint Bone Spine Jan 22. [Epub ahead of print] 7. Vieth R. Vitamin D supplementation, 25 hydroxyvitamin D concentrations, and safety. Am J Clin Nutr May;69(5): Review.

59 Vitamin D Contraindications Contraindications Certain medical conditions can increase the risk of hypercalcaemia in response to vitamin D People with some conditions may develop hypercalcaemia in response to any increase in vitamin D nutrition and should consult a qualified health care provider regarding any increase in vitamin D intake People with known hypersensitivity to vitamin D should be cautious Not recommended for concomitant use with Calcitriol medications (a Vitamin D metabolite)

60 Contraindication Medicines Vitamin D absorption and/or metabolism may be affected by some medication

61 The Ostelin Range

62 Ostelin is Halal accredited The Product Range

Ostelin Vitamin D Each capsule contains: Vitamin D3 1000 IU equiv to cholecalciferol 25 mcg Adult Dosage: 1 capsule daily with a meal, or as directed by your healthcare professional Free from gluten,

63 Ostelin Vitamin D Each capsule contains: Vitamin D IU equiv to cholecalciferol 25 mcg Adult Dosage: 1 capsule daily with a meal, or as directed by your healthcare professional Free from gluten, sugar, starch, lactose, yeast and artificial colours or flavours, artificial sweeteners or preservatives or dairy products Contains vitamin D3 which is the form that is produced naturally in the body

64 Vitamin D Benefits Improves the absorption of dietary calcium (a diet deficient in calcium can lead to osteoporosis in later life) Helps maintain muscle function and strength 28 Reduces risk of falls in the elderly 28 Supports immune system function 28 Supports bone mineral density Important throughout pregnancy for the developing baby Brown AJ, Dusso A, Slatopolsky E, Vitamin D. American Journal of Physiology.1999; 277(2):F Kimlin M, Harrison S, Nowak M, et al. Does a high UV environment ensure adequate vitamin D status? J Photochem Photobiol B Dec 14;89(2 3):

Each capsule contains: Ostelin Osteoguard Vitamin D3 500 IU (as cholecalciferol 12.5mcg) Calcium 600 mg (as calcium carbonate 1.5g) Magnesium 52.5mg (as magnesium citrate nonahydrate 195.

65 Each capsule contains: Ostelin Osteoguard Vitamin D3 500 IU (as cholecalciferol 12.5mcg) Calcium 600 mg (as calcium carbonate 1.5g) Magnesium 52.5mg (as magnesium citrate nonahydrate 195.7mg and Magnesium oxide heavy 51.5mg) Vitamin K1 (Phytomenadione) 100mcg Boron 1.5mg (as Boric Acid 8.6mg) Manganese 2mg (as Manganese sulfate monohydrate 6.2mg) Suggested adult dosage: 2 tablets daily with food, or as directed by your healthcare professional. No added yeast, gluten, lactose, artificial colours or flavours, artificial sweeteners or preservatives or dairy products.

Ostelin Osteoguard Ostelin Osteoguard is a high potency complex, specially formulated with 6 levels of support for strong bones Vitamin D promotes calcium absorption and is essential throughout life

66 Ostelin Osteoguard Ostelin Osteoguard is a high potency complex, specially formulated with 6 levels of support for strong bones Vitamin D promotes calcium absorption and is essential throughout life to help maintain healthy bone structure Calcium assists in maintaining peak bone mass and increasing bone mineral density Vitamin K works synergistically with vitamin D for bone health and helps the body transport calcium. Vitamin K is a cofactor for osteocalcin, a protein which influences bone mineral density 1 Boron has a favourable impact on calcium metabolism and therefore a role in the maintenance of normal bone Adequate manganese helps maintain healthy bones & joints Magnesium is required by the body for normal bone function and bone metabolism 1. Z. Jasminka & J. Kerstetter. Journal of the American College of Nutrition, 2000: Vol. 19, No. 6,

67 Ostelin Vitamin D & Calcium Each tablet contains: Vitamin D3 500 IU equiv to cholecalciferol 12.5 mcg Calcium carbonate 1500 mg equiv. to elemental calcium 600 mg Adult dosage: 2 tablets daily with a meal, or as directed by your healthcare professional Free from gluten, lactose, yeast, artificial sweeteners or flavours, artificial preservatives or dairy products

68 Ostelin Vit D & Calc Chewable Each chewable tablet contains: Vitamin D3 500 IU equiv to cholecalciferol 12.5 mcg Calcium carbonate 1500 mg equiv. to elemental calcium 600 mg Adult dosage: Chew 2 tablets daily with a meal, or as directed by your healthcare professional Free from lactose, yeast, artificial colours and flavours, artificial preservatives or dairy products Citrus Flavour

Calcium supplementation may be of assistance in the prevention &/or treatment of osteoporosis Maintenance of healthy bones Helps

69 Vitamin D & Calcium Benefits High Strength Calcium & Vit D supplement 600mg of elemental Calcium & 500 IU Vit D per tablet/chewable tablet Source of calcium. Women s calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention &/or treatment of osteoporosis Maintenance of healthy bones Helps maintain muscle strength, which may reduce the risk of falls in older people Correction of Vitamin D deficiency Uses Vitamin D3 which is the form that is produced naturally in the body (bioactive)

the body * Convenient Dose flexibility Ease of swallowing

70 Ostelin Liquids Range The benefits of liquids Alternative to tablets/capsules Liquid form is more readily available to the body * Convenient Dose flexibility Ease of swallowing Can be mixed with other liquids * when compared to solid dose forms

71 Targeting Severe Deficiency New format satisfying two consumer segments 1. Australians suffering moderate severe deficiency Consumers with difficulty swallowing capsules 8. Audran M, Briot K. Critical reappraisal of vitamin D deficiency. Joint Bone Spine Jan 22. [Epub ahead of print] 9. ANZ Bone and Mineral Society. "Vitamin D and adult bone health in Australia and New Zealand: a position statement." Med J Aust 2005;182(6):

72 Ostelin Vitamin D Liquid Ostelin Vitamin D Liquid 50mL Liquid Orange flavour Ingredients: Each 0.5mL contains: Vitamin D3 1000IU (25mcg cholecalciferol) Dosage: For adults and children over 12 years, take 0.5mL daily or as directed by your healthcare professional

Vitamin D Liquid - Features Key features Easy to use 3mL measuring applicator for accurate dosing Natural orange flavour No added yeast, starch,

73 Vitamin D Liquid - Features Key features Easy to use 3mL measuring applicator for accurate dosing Natural orange flavour No added yeast, starch, lactose, sugar, artificial colours or flavours, artificial sweeteners or preservatives, gluten, dairy products 1000IU of vitamin D3 per 0.5mL dose

74 Ostelin Vitamin D Liquid Kids Ostelin Vitamin D Liquid Kids 20mL Liquid Strawberry flavour Ingredients: Each 0.5mL contains Vitamin D3 200IU (Cholecalciferol 5mcg) Dosage: For infants and children under 12 years General supplementation take 0.5mL daily or as directed by your healthcare professional Supplementation for at risk groups take 1mL daily or as directed by your healthcare professional

75 Vitamin D Liquid Kids - Features Key features Easy to use 1mL measuring applicator for accurate dosing Natural strawberry flavour No added yeast, sugar, artificial colours or flavours, artificial sweeteners or preservatives, gluten, dairy products or lactose Contains 200IU* of vitamin D3 per 0.5mL dose *200IU is the adequate intake amount as recommended by the National Health and Medical Research Council for infants, children and adolescents.

76 FDA Compliance To assist in parents dosing their child it is recommended by the FDA that an accurate measuring dispenser is used which does not go beyond 400IU of vitamin D3 Ostelin Vitamin D Liquids Kids provides this 30. Food and drug administration Guidance, Compliance & Regulatory Information > FDA Letter to Industry Concerning Liquid Vitamin D 2011

77 Consumer Profile Which Kids are at risk? Infants of vitamin D deficient mothers Infants who are solely breast fed for long periods Children with reduced sun exposure (modest clothing, indoor lifestyle etc) Children with dark pigmented skin

78 Vitamin D Liquid Competitors Product Ostelin Vitamin D Liquid Ostelin Vitamin D Liquid Kids Ingredients Vitamin D3 cholecalciferol 1000IU(25mcg)/0.5mL Vitamin D3 cholecalciferol 200IU(5mcg)/0.5mL Ostevit D Liquid Vitamin D3 cholecalciferol 1000IU(25mcg)/0.2mL Pack Size 50mL 20mL 50mL 50mL Flavour Orange Strawberry Unflavoured Vanilla Applicator Dose Accurate measuring dispenser For adults and children over 12 years of age Take 0.5mL daily or as directed by your Healthcare professional Accurate measuring dispenser For infants and children under 12 years of age take 0.5mL daily or as directed by your Healthcare professional Squeeze dropper Dosage for adults and children over 12 years of age take 0.2mL daily, as directed by your healthcare Professional. Children under 12 years of age as directed by your Healthcare professional BioCeuticals D3 Drops (Practitioner Only) Vitamin D3 Cholecalciferol 1000IU(25mcg)/0.11mL Squeeze bottle Adults take 1 drop up to 3 times daily or take 25mcg (3 drops) once daily. Children and Adolescents give 1 drop up to 3 times daily or as directed by your Healthcare professional Current at Nov 2011

79 Vitamin D Benefits Summary Improves the absorption of dietary calcium and a diet deficient in calcium can lead to osteoporosis later in life May reduce the risk of fractures and falls in the elderly Supports bone mineral density Helps maintain muscle function and strength Supports immune system function Important throughout pregnancy for the developing baby

80 Ostelin Summary Australia s # Bone Health brand Australia s # Vitamin D brand #5 Pharmacy brand #1 selling nutra product in Pharmacy (units) Halal accredited Available in 4 formulations Capsules, Liquid, Tablets & Chewable tablets

81 Additional information for detailing to Doctors and Pharmacists only For training purposes only. For Doctors and Pharmacists only. Not for public distribution.

82 For training purposes only. For Doctors and Pharmacists only. Not for public distribution. Rickets

83 Signs and Symptoms: Softening and weakening of bones Muscle weakness Skeletal deformity bow legged, knock knees Bone pain Growth disturbance Dental problems For training purposes only. For Doctors and Pharmacists only. Not for public distribution. At risk profile & symptoms Rickets is rare in Australia and more commonly found in developing countries. Children aged 6 months 24 months are at highest risk, because their bones are rapidly growing. Long term consequences include permanent bends or disfiguration of the long bones, and a curved back. Check with your healthcare professional. Those at higher risk for developing vitamin D deficiency include 6 : Infants whose mothers were vitamin D deficient during pregnancy Breast fed infants whose mothers are not exposed to sunlight Breast fed infants who are not exposed to sunlight Babies with dark complexions Individuals not consuming vitamin D fortified milk 6. Munns C, Zacharin MR, Rodda CP,et al. Paediatric Endocrine Group; Paediatric Bone Australasia. Prevention and treatment of infant and childhood vitamin D deficiency in Australia and New Zealand: a consensus statement. Med J Aust. 2006;185(5):268 72

84 For training purposes only. For Doctors and Pharmacists only. Not for public distribution. Osteomalacia

85 For training purposes only. For Doctors and Pharmacists only. Not for public distribution. Osteomalacia definition The softening of the bones due to defective bone mineralisation secondary to inadequate amounts of available phosphorus and calcium It may show signs as diffuse body pains, muscle weakness, and fragility of the bones Osteomalacia in children is known as rickets and because of this, use of the term osteomalacia is often restricted to the milder, adult form of the disease The most common cause of the disease is a deficiency in vitamin D. Check with your healthcare professional.

86 For training purposes only. For Doctors and Pharmacists only. Not for public distribution. Vitamin D for Osteoporosis Calcium and vitamin D appear to enhance the effect bisphosphonates 31 e.g Actonel Bisphosphonates are widely used in the treatment of osteoporosis and prevention of osteoporosis related fractures. In a study conducted in 2007, the results show that in the first study group, subjects with serum vitamin D concentrations (> 70 nmol/l) had a significantly lower serum PTH level (mean [SEM] 41 [2] ng/l). PTH concentrations of 41 ng/l or less was associated with a significantly higher increase in BMD at the hip following treatment with bisphosphonates compared to patients with PTH > 41 ng/l (2.5% [0.9] v/s 0.2% [0.9], P = 0.04). In the second study group, discontinuation of bisphosphonates for 15 months after long term treatment did not result in significant bone loss at the lumbar spine and total hip, although a trend towards gradual decline in BMD at the femoral neck was observed. 31. Deane A, et al. The impact of vitamin D status on changes in bone mineral density during treatment with bisphosphonates and after discontinuation following long term use in post menopausal osteoporosis. BMC Musculoskelet Disord Jan 10;8:3.

87 For training purposes only. For Doctors and Pharmacists only. Not for public distribution. Recommend with Medication All recent osteoporosis guidelines recommend that patients taking treatment for osteoporosis (i.e. bisphosphonates), should be supplemented with vitamin D and calcium. 32. Bruyere O, Reginster JY. Vitamin D status and response to antiosteoporotic therapy. Women s Health (Lond Engl) Sep;4(5):445 7

88 For training purposes only. For Doctors and Pharmacists only. Not for public distribution. Bisphosphonates less Calcium In general, bisphosphonates are poorly absorbed from the GI tract and can bind calcium Bisphosphonates should be takenonanemptystomachwith a30 60minutepost dose fast Avoid taking calcium supplements around the dose of oral bisphosphonates 33. Sunyecz JA. The use of calcium and vitamin D in the management of osteoporosis. Ther Clin Risk Manag Aug;4(4):

89 For training purposes only. For Doctors and Pharmacists only. Not for public distribution. Contraindication Medicines Vitamin D absorption and/or metabolism may be affected by some medication For example: Rifampin (antibiotic) increases vitamin D metabolism and reduces vitamin D blood levels 34 Anti epileptic agents such as Phenytoin (Dilantin) 35 and Carbamazepine (Tegretol) 27 may accelerate conversion of vitamin D to inactive metabolites through liver induction 34. Rifadin (Rifampin) Product Information aventis.us/rifadin/rifadin.pdf 35. Dilantin (Phenytoin) Product Information found at Linus Pauling Institute. Vitamin D. (accessed 15/05/11)

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In addition to bone health, emerging science reveals a non-skeletal benefit of vitamin D for several other health outcomes.

In addition to bone health, emerging science reveals a non-skeletal benefit of vitamin D for several other health outcomes. Vitamin D AT A GLANCE Introduction Vitamin D comprises a group of fat-soluble compounds that are essential for maintaining the mineral balance in the body. The vitamin D form synthesized in humans is called