GUIDELINES FOR THE MANAGEMENT OF VITAMIN D DEFICIENCY

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GUIDELINES FOR THE MANAGEMENT OF VITAMIN D DEFICIENCY This document provides management guidelines for clinicians involved in the management of patients with or at risk of Vitamin D deficiency.

Three Villages Medical Practice Leanne Nation, Principal Pharmacist, DGNHSFT Dr Andrew Whallett, Consultant Rheumatologist, DGNHSFT Version Control Nov 2018 3.

2 Guidelines updated to include licensed product- Invita D3 oral Solution- approved by ACE on 14.5.15 July 2014 1.

1 GUIDELINES FOR THE MANAGEMENT OF VITAMIN D DEFICIENCY This document provides management guidelines for clinicians involved in the management of patients with or at risk of Vitamin D deficiency. Authors: Dr Ruth Edwards, GP, Albion House Surgery & CCG board member Clair Huckerby, Pharmaceutical Adviser, Dudley CCG Jas Johal, Pharmaceutical Consultant, Dudley CCG Dr Jennifer Marwick, GP, Three Villages Medical Practice Leanne Nation, Principal Pharmacist, DGNHSFT Dr Andrew Whallett, Consultant Rheumatologist, DGNHSFT Version Control Nov Updated to include Stexerol D3- approved by ACE on May Updated Guidelines for the Management of Vitamin D deficiencyapproved by ACE on January Guidelines updated to include licensed product- Invita D3 oral Solution- approved by ACE on July Guidelines for the Management of Vitamin D deficiency- final version approved by AMMC April Draft Guidelines for the Management of Vitamin D deficiency April Vitamin D deficiency guidance Ratification date: Nov 2018 Review date: Nov 2020 Consultation/Acknowledgements Jagdeep Sangha- Pharmaceutical Advisor- Community Pharmacy and Public Health Lisa Truefitt- Medicines Management Dietician Rachael Thornton- Older Persons Specialist Pharmacist Sukvinder Sandhar, Sarah Baig Primary care Pharmacists DGNHSFT Consultants: Dr A Akula, Dr H Ashby, Dr P Mohammed, Dr Duja, Dr Michael Medicines Management Team NHS Telford & Wrekin 1

2 Vitamin D deficiency guidance ADULTS-Management Flowchart Does the patient have any risk factors or symptoms? (see appendix 1) No No investigations required. Give lifestyle advice (appendix 3) Risk factors & Symptoms/Signs Lifestyle advice (appendix 4) Yes If indicated arrange Investigations (See appendix 2.1) Risk factors Only Lifestyle advice- No investigations are required if the patient is asymptomatic.(appendix 4) Recommend daily self treatment with supplement of colecalciferol 400i IU daily unless contraindicated. (appendix 5) Patients > 65 years who are housebound or resident in care facility with limited exposure to sunlight may be more likely to take a Vitamin D only supplement than one that is combined with calcium. Therefore a Vitamin D supplement e.g. Desunin 800 IU tablets- one daily should be prescribed unless a combined Calcium and Vitamin D supplement (e.g. Adcal D3) is otherwise specifically indicated (see appendix 2). Management of sufficient Vitamin D levels >50nmol/l Reassure and give lifestyle advice (see appendix 4) Management of Insufficiency Vitamin D levels 30-50nmol/L Recommend that the patient purchases colecalciferol IU daily Treatment of Deficiency* Vitamin D levels<30nmol/l Prescribe: Invita D3 50,000IU every week for 6-8 weeks (either as oral solution or capsules) OR Stexerol-D 3 50,000 IU every week for 6 weeks Then recommend life-long daily self treatment with supplement of colecalciferol IU daily unless contraindicated (see appendix 6) Invita D3 oral solution- lactose free, gelatine free, nut free and soya free. Suitable for vegetarians. N.B. capsules contain gelatine. Stexerol D3 25,000IU tabs approved for use as a treatment dose for patients in primary care who cannot use Invita D3 but may be used in secondary care as a first line treatment dose. All pregnant and breastfeeding women should take a daily supplement containing 400 IU (10mcg) of vitamin D, to ensure the mother s requirements for vitamin D are met and to build adequate foetal stores for early infancy Refer to midwife for further information on availability and eligibility for Healthy Start vitamins. See appendix 3 Desunin tabs- gelatine free, peanut oil and soya free. Suitable for vegetarians Criteria for Referral to secondary care (Appendix 5): Skeletal deformity Focal bone pain Significant renal impairment Advanced liver disease Raised corrected calcium or known hyperparathyroidism Failure to respond or intolerance to supplementation Unexplained severe deficiency Low calcium with or without symptoms Persisting low serum phosphate or low/high alkaline phosphatase Pregnancy (if there s insufficiency/deficiency) N.B. capsules contain gelatine. *Monitoring As vitamin D has a relatively long half-life, levels will take approx. 3-6 months to reach steady state after loading dose or maintenance treatment. 1. Assess serum calcium levels 1 month after administration of last loading dose. 2. Routine monitoring of serum 25OHD is generally unnecessary but may be appropriate in patients with symptomatic vitamin D deficiency or malabsorption and where poor compliance with medication is suspected. Recheck after 1 year if needed. Further assessment required Refer to specialist 2

3 Vitamin D deficiency guidance CHILDREN-Management Flowchart Does the patient have any risk factors or symptoms? (see appendix 1) Risk factors & Symptoms/Signs Yes Lifestyle advice (appendix 4) Arrange Investigations (See appendix 2.1) OR CONSIDER REFERRAL TO A PAEDIATRICIAN Management of sufficient Vitamin D levels >50nmol/l If symptoms are present refer to specialist (see appendix 5) Management of Insufficiency Vitamin D levels 30-50nmol/L Provide lifestyle advice and prescribe prevention dose: Thorens 10,000iu/ml oral drops solution (1 drop: 200iu) Dose 0-1 year: 400iu or 2 drops per day Dose 1-18 years: 600iu or 3 drops per day Treatment of Deficiency* Vitamin D levels <30nmol/L The analytical variability of the vitamin D assay at the lower level may be up to 10% (so a result of 25 could be 27.5 and similarly result of 30 could be lower) no adverse clinical outcome is shown and treatment is justified in this very small group of children earlier (25-30 range) Lifestyle advice and prescribe below doses as per RCPCH guidelines Thorens 10,000iu/ml oral drops solution (1 drop: 200iu) Category Dose and frequency (off-label) Duration Course quantity Up to 6 months 6 months 12 years years units daily (5 drops or 0.1ml to 15 drops or 0.3ml daily) 6000 units daily (30 drops or 0.6ml daily) 10,000 units daily (50 drops or 1ml daily) Risk factors Only 1ml oral syringe should be provided 4-8 weeks 2 bottles 4-8 weeks 4 bottles 4-8 weeks 6 bottles Assess risk factors/signs and symptoms, and review calcium intake then prescribe prevention dose as above, Abidec, Dalivit or recommend Healthy Start vitamins or OTC vitamin supplementation Thorens oral solution- Suitable for vegetarians. Contains refined olive oil No No investigations required. Give lifestyle advice (appendix 4) Offer Lifestyle advice (appendix 4) SACN recommends that all children should consume the following levels of vitamin D daily: 0-1 year: 340 to 400 units daily 1 year(s): 400 units daily Dietary sources of vitamin D include natural and fortified foods (including infant formula) and supplements. Those infants who are fed infant formula will not need vitamin D drops until they are receiving less than 500ml of infant formula a day. Check dietary calcium intake. Breastfed infants may need to receive drops containing vitamin D from one month of age if their mother has not taken vitamin D supplements throughout pregnancy. Recommended OTC vitamin D Supplementation 0-1 year: iu daily 1 year and over: 400iu daily For children from 6 months to under 4 years of age Healthy Start vitamins are available. 5 drops of healthy start vitamins will provide 300iu of Vitamin D. For further information on availability and eligibility for Healthy Start vitamins refer to health visitor. (See appendix 3). Vitamin supplements may be provided to infants under six months, if healthcare professionals consider that their vitamin stores are likely to be low and supplements would benefit them (See appendix 6). Criteria for Referral to secondary care (appendix 5): Skeletal deformity Focal bone pain Significant renal impairment Advanced liver disease Raised corrected calcium or known hyperparathyroidism Failure to respond to supplementation Unexplained severe deficiency Low calcium with or without symptoms Persisting low serum phosphate or low/high alkaline phosphatase Has a co-existing condition associated with increased sensitivity to vitamin D i.e. sarcoidosis, tuberculosis, lymphoma, or primary hyperparathyroidism *Monitoring As vitamin D has a relatively long half-life, levels will take approx. 3-6 months to reach steady state after loading dose or maintenance treatment. 1.. Routine monitoring of serum 25OHD is generally unnecessary but may be appropriate in patients with symptomatic vitamin D deficiency or malabsorption and where poor compliance with medication is suspected.# Recheck after 1 year if needed. Further assessment required Refer to specialist #Consider a clinical review a month after treatment starts, asking to see all vitamin and drug bottles. A blood test can be repeated then, if it is not clear that sufficient vitamin has been taken. Current advice for children who have had symptomatic Vitamin D deficiency is that they continue maintenance prevention dose at least until they stop growing. 3

4 Appendix 1 Risk Factors and Clinical Features for Vitamin D Deficiency Risk factors for Vitamin D deficiency Inadequate UV exposure Limited sun exposure Air Pollution Occlusive garments Pigmented skin Habitual sunscreen use Institutionalised/ housebound and people with poor mobility e.g. wheelchair bound Poor Dietary intake/ impaired absorption Vegetarian/Vegan (or infrequent intake of oily fish or egg yolk), Diet insufficient in calcium or vitamin D Other reasons: Malabsorption, including short bowel and cholestatic jaundice Colestyramine use Breastfed infant. Metabolic risk Reduced synthesis Increased breakdown Drugs including rifampicin, anticonvulsants, HAART therapy, glucocorticoids. Liver disease Kidney disease Pregnancy and Breastfeeding Clinical features of Vitamin D deficiency Symptoms, Sign, Biochemistry Children Adult Seizures Tetany Hypocalcaemia Irritability Leg bowing Knock knees Impaired linear growth Delayed walking Limb girdle pain Muscle pain Proximal myopathy Impaired innate antimycobacterial immunity 4

5 Appendix 2 Vitamin D Testing Who should be tested for vitamin D deficiency? The number of vitamin D measurements requested in the UK has increased in recent years, such that testing for vitamin D deficiency has become routine in clinical practice, despite considerable uncertainty about who to test and whether low results are related to the patient s symptoms or illness. In some areas, requests are made to measure serum 25OHD for unclear clinical indications, resulting in large numbers of tests. Good-practice principles should always be adopted when considering testing for 25OHD. These include being able to justify that the result will affect clinical management, being aware that the relationship between the patients symptoms and 25OHD concentration is not always consistent given the high prevalence of vitamin D deficiency, and being aware of how to interpret findings. 5

6 Patients with bone diseases (a) that may be improved with vitamin D treatment or (b) where correcting vitamin D deficiency prior to specific treatment would be appropriate This group primarily comprises patients who have osteomalacia or osteoporosis. Patients with osteomalacia often complain of multiple symptoms including bone, joint and muscle pain, hyperalgesia, muscle weakness and a waddling gait. There is good evidence that correcting vitamin D is essential in osteomalacia, but it is also likely to be beneficial in osteoporosis. There are other bone diseases where correcting vitamin D deficiency before drug treatment is recommended, such as when treating Paget s disease with a bisphosphonate. Correction of vitamin D deficiency is also required before starting osteoporosis treatment with a potent antiresorptive agent (zoledronate or denosumab), to avoid the development of hypocalcaemia. Nevertheless, routine 25OHD testing may be unnecessary in patients with osteoporosis or fragility fracture, where a decision has been made to co-prescribe vitamin D supplementation with an oral antiresorptive treatment. Patients with musculoskeletal symptoms that could be attributed to vitamin D deficiency Symptoms of vitamin D deficiency are unfortunately vague and it can be difficult to ascertain whether a low serum 25OHD level is causal or a surrogate marker (e.g. of poor nutrition or a lack of outdoor activity). Nonetheless, if patients are suspected of having symptoms caused by osteomalacia, or have chronic widespread pain, a case can be made to measure serum 25OHD as part of their clinical and laboratory evaluation. Asymptomatic individuals at higher risk of vitamin D deficiency There are a number of risk factors in asymptomatic individuals that predispose to lower levels of 25OHD. These individuals are more likely to be vitamin D-deficient and current UK guidance from the Department of Health recommends that these individuals have a higher intake of vitamin D (see box below). Recommendation: Do not routinely test 25OHD levels in these groups. Asymptomatic healthy individuals Although vitamin D deficiency is highly prevalent, universal screening of asymptomatic populations is not recommended. Age Groups and Vitamin D Deficiency: Children Risk factors- Partially or exclusively breastfed infants; Black and Ethnic Minority Risk factors and clinical symptoms: Bow legs, poor growth, reluctance to start walking, late teething, irritability, breathing difficulty, cardiomyopathy, seizures Or consider referral to a Paediatrician. Patients > 65 years who are housebound or resident in care facility Residents of care homes may find supplements containing calcium and vitamin D harder to swallow and these may cause side effects such as constipation. In addition, care homes residents, particularly those with poor nutritional intake tend to have a high intake of dietary calcium through the recommended use of milk and other dairy products. Care home residents therefore should be prescribed a Vitamin D only supplement e.g. Desunin 800 unit tablets, rather than a supplement 6 containing calcium and vitamin D unless otherwise specifically indicated.

7 Appendix Investigations Arrange the following investigations for patients presenting with risk factors and symptoms: Renal function Bone profile Vitamin D levels For other causes of myalgia- consider: CRP ESR TFTs Glucose LFTs FBC CK 7

8 Appendix 3 Healthy Start Vitamins Healthy Start Scheme is a UK wide means-tested statutory scheme providing pregnant women, women with a child under 12 months and children aged from six months to four years free Healthy Start vitamins. The scheme provides coupons which can be exchanged for Healthy Start vitamin supplements. Children who are having 500ml or more of formula a day do not need Healthy Start vitamins. For further information refer to the Healthy Start children s vitamin drops decision tree Further information about eligibility for free healthy start vitamins is available from Health Visitors and midwives or at or contact Healthy Start Vitamins are now also available from community pharmacies within Dudley. Appendix 4 Lifestyle Advice Safe sun exposure For adults in the UK exposure of the hands, face and arms for minutes (this increases to 3-10 times for dark pigmented skin) on most days during the summer months (April to September) is estimated will provide sufficient exposure to the ultraviolet B wavelengths (UVB) to achieve healthy Vitamin D levels. Sunscreens with SPF 15 or greater are essential to prevent skin damage with longer sun exposure but will reduce Vitamin D synthesis by 99% Advising to omit sunscreen for short, incidental sun exposures would be reasonable. Deliberate exposure to sunlight between 11:00 and 15:00 in the summer months is not advised NB. For the six months between October and April 90% of the UK lies above the latitude that permits exposure to the UVB that is necessary for Vitamin D synthesis. During these months people are reliant on exogenous sources i.e. from diet or supplementation Diet Rich sources include cod liver oil (this also contains vitamin A which can be harmful in high doses and should be avoided in pregnancy), oily fish (such as salmon, mackerel, and sardines). Egg yolk, meat, offal, milk, mushrooms, and fortified foods (such as fat spreads and some breakfast cereals and yoghurts) contain small amounts. It is important to maintain dietary intake of vitamin D by taking vitamin D supplements, especially during the winter months, as it is difficult to obtain sufficient vitamin D from food sources alone because they are limited. It is also important to maintain dietary intake of calcium, as both calcium and vitamin D are needed to prevent long-term adverse effects on the bones. Rich sources of calcium include dairy foods (milk, cheese, and yoghurts) and tinned sardines with bones. The daily requirement of vitamin D is: 0-1 year: 340 to 400 units daily 1 year(s): 400 units daily 8

9 Appendix 5 Referral to Secondary Care Indications for referral to secondary care - Consider referral to geriatrician for advice in those over 65 years - Send request for advice to rheumatologist Skeletal deformity Focal bone pain Significant renal impairment Advanced liver disease Raised corrected calcium / known hyperparathyroidism Failure to respond or intolerance to supplementation Unexplained severe deficiency Low calcium with or without symptoms Persisting low serum phosphate or low/high alkaline phosphatase Vitamin D deficiency/insufficiency in pregnancy Has a co-existing condition associated with increased sensitivity to vitamin D i.e. sarcoidosis, tuberculosis, lymphoma, or primary hyperparathyroidism Appendix 6 - OTC preparations (list not exhaustive and prices taken from internet search 4 th Feb These are subject to change.) Product IU per dose form quantity price per pack price per dose Dalivit drops (0.6ml dose) 400 Drops 25ml Abidec drops (0.6ml dose) 400 Drops 25ml Holland & Barrett - Vitamin D3 (25ug) 1000 caplets FSC - Vitamin D3 Tablets (400 iu) Holland & Barrett 400 tablets Valupak Vitamin D3 Tablets (12.5ug) 1000 tablets Holland & Barrett - Vitamin D3 Tablets (10ug) 400 tablets D Drops ONE Liquid Vitamin D3 (10ug) 400 liquid 1.7ml (60 Drops) VIT HEROES. CALCIUM AND VITAMIN D AGES 3-12 YEARS. VANILLA FALVOURED GUMMY BEARS 5µg 200IU gum shape HALIBORANGE. KID VITAMIN D + CALCIUM SOFTIES 3- gum 12YEARS, STRAWBERRY SHAPES 5µg 200IU shape ASDA VITAMIN D TABLETS 25µg 1000IU tablets

10 References 1) Pearce SHS, Cheetham T: Diagnosis and management of vitamin D deficiency. BMJ 2010; 340:b5664 2)UKMI What dose of vitamin D should be prescribed for the treatment of vitamin D deficiency. Nov ) Children's BNF 2017/18 accessed via MedicinesComplete (April 2018) 4) Vitamin D and Bone Health: A Practical Clinical Guideline for Adult Patient Management. National Osteoporosis Society April ) Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management in children and Young People. National Osteoporosis Society June ) Guide for Vitamin D in childhood. RCPCH. Oct ) NICE Clinical Knowledge Summaries: Vitamin D deficiency in adults - treatment and prevention, updated Nov ) NICE Clinical Knowledge Summaries: Prevention of vitamin D deficiency in Children, updated Nov ) Vitamin D: supplement use in specific population groups. NICE Public health guideline PH56. 10) Vitamin D and Health, Scientific Advisory Committee on Nutrition, July ) Invita D3 50,000IU Solution, Consilient Health Limited; Summary of Product Characteristics accessed on 14/03/18 at: 12) Invita D3 50,000IU Soft Capsule, Consilient Health Limited; Summary of Product Characteristics accessed on 14/03/18 at: 13) Thorens 10,000 units/ml Oral Drops, Solution; Galen Limited; Summary of Characteristics accessed on 14/03/18 at: 10

1. Adults; a. Risk factors. b. Who should be tested for vitamin D deficiency? c. Investigations. d. Who do we treat and how do we treat? 2.

1. Adults; a. Risk factors. b. Who should be tested for vitamin D deficiency? c. Investigations. d. Who do we treat and how do we treat? 2. Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management For Adults and Children Adapted from existing local guidance, National Osteoporosis Society Practical Guides and from Royal