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.

Transcription

1 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 College of Paediatrics and Child Health s Guide for Vitamin D in Childhood 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. Children; a. Risk Factors b. Who should be tested for vitamin D deficiency? c. Investigations d. Who do we treat? 1

2 1. ADULTS 1.1 Risk factors of vitamin D deficiency All pregnant and breastfeeding women, especially teenagers and young women Older people, aged 65 years and over. Pigmented skin tone Lack of sun exposure Malabsorption, short bowel syndrome, cholestatic liver disease, coeliac disease Non-fish eating diet Use of anticonvulsants, rifampicin, colestyramine, HAART, glucocorticoids Management of patients at risk of vitamin D deficiency but who are currently asymptomatic All patients with risk factors must be offered lifestyle and diet advice, including patient information leaflet if available. Not all at risk patients will require prescribed therapy. Not all at risk patients will be symptomatic. Do not request Vitamin D tests for asymptomatic patients. Asymptomatic BUT at risk All pregnant and breastfeeding women, especially teenagers and young women People aged 65 and over and people who are housebound who are confined indoors for long periods Patients with diseases with outcomes that may be improved with vitamin D treatment e.g. confirmed osteomalacia and osteoporosis Management - No vitamin D level test required. All pregnant and breastfeeding women should take vitamin D. Advise healthy start vitamin supplements if eligible or purchase over the counter preparation 400 units daily. People aged 65 years and over and people who are not exposed to much sun should be prescribed a daily supplement containing 1000 mg calcium and 400 units vitamin D see current formulary for preferred brand Osteoporosis: prescribe a daily supplement containing 1000 mg calcium and 400 units of vitamin D see current formulary for preferred brand Osteomalacia: prescribe 400 units of vitamin D with calcium if needed Who should be tested for vitamin D deficiency? Routine testing of vitamin D levels is NOT recommended. Vitamin D deficiency or insufficiency should be considered and checked for ONLY if patients are symptomatic, have other risk factors and where other causes for symptoms have been excluded. Vitamin D testing should only be done in patients with symptoms indicative of bone diseases that may be improved with vitamin D treatment: Rickets Osteomalacia Symptomatic hypocalcaemia Patients with musculoskeletal symptoms that can be attributed to vitamin D deficiency Symptoms of vitamin D deficiency in adults: Chronic widespread pain / Hyperalgesia Bone, joint and muscle pain Muscle weakness Waddling gait 2

3 1.4. Adults with the following features should be referred to a specialist. Patients with granulomatous disease, tuberculosis, liver disease, renal disease chronic malabsorptive disorders and active sarcoidosis must be referred to a specialist BEFORE starting these patients on vitamin D therapy Investigations for symptomatic adults. Routine Vitamin D level testing is NOT recommended. Initial Investigations Vitamin D assay No routine testing- local interval between tests is no less than 12 months Liver and renal function Full blood count- anaemia may be present if malabsorption Calcium level to exclude hypercalcaemia and obtain baseline for monitoring - if low vitamin D confirmed and calcium is raised or high-normal, check parathyroid hormone. Do not check parathyroid hormone routinely 1.6. Which adults do we treat and how do we treat? Serum 25- hydroxyvitamin D concentrations 3 Status Who should we treat? Regimen Oral administration of vitamin D is recommended <30 nmol/l Deficiency All patients with status of deficiency: high dose Treatment initially, then long term Maintenance treatment required including lifestyle and diet advice Rapid correction or second option (below) Then Long term maintenance Treatment dose - WHERE RAPID CORRECTION IS NOT REQUIRED: Oral colecalciferol 3,200 units daily for up to 13 weeks Prescribe colecalciferol as Fultium-D 3 (licensed medicine) 3200 unit capsules; 1 x 3200 unit capsule once daily for 13 weeks Then: long term maintenance 800 units daily purchased over the counter or Treatment dose - RAPID CORRECTION REGIMEN: Oral colecalciferol. 2 x 1ml 25,000 snap and squeeze ampoule given weekly for 6 weeks. Prescribe colecalciferol as InVita D3 (licensed product ) 2x 25,000 unit/ 1ml Oral Solution. Then: long term maintenance 800 units daily purchased over the counter IF ADHERENCE IS A PROBLEM OR WHERE RAPID CORRECTION IS REQUIRED BUT ORAL PREPARATIONS UNSUITABLE: Intramuscular injection (IM) may be used 300,000 units is given as a single dose. Patient must be referred to secondary care specialist if clinical response is not achieved within 3 months of initial treatment dose. Secondary care may repeat the treatment dose after 3 4 months. If the injection is used, monitor serum and urinary calcium, phosphate and renal function to avoid changes in serum calcium. OTHER LEVELS Status Who should we treat? Regimen nmol/l Insufficiency Long term maintenance with over the counter preparation. Start one month after completing high dose treatment if applicable nmol/l Healthy Maintenance with over the counter preparation. Over the counter dose of units daily, long term. Diet and lifestyle advice. Over the counter dose of units daily, long term. Diet and lifestyle advice >75 nmol/l Optimal Lifestyle and diet advice only Consider and explore other reasons for symptoms

4 2. Children 2.1 Risk factors of Vitamin D deficiency in children Category Risk factors Increased need Infants and children between the ages of six months and five years Twin and multiple pregnancies Adolescents Obesity (metabolic conditions) Reduced sun exposure People with darker skin, for example people of African, African-Caribbean or South Asian origin Wearing concealing clothing Immobility, e.g. inpatients or those with conditions like cerebral palsy Excessive use of sun block - most block UVB more than UVA Limited diet (but remember sunshine is most important source of vitamin D Vegetarians and vegans Prolonged breastfeeding even if mother has sufficient vitamin D Exclusion diets e.g. milk allergy Malabsorption (seek specialist advice before treatment) Liver disease (seek specialist advice before treatment) Renal disease (seek specialist advice before treatment) Some drugs e.g. P450 enzyme inducing drugs such as anticonvulsants, anti-tb drugs (seek specialist advice before treatment) 2.2 Management of asymptomatic at risk children NO Vitamin D Level test required At risk group Newborn up to 1month (exclusively breastfed) Prevention Dose and frequency for ASYMPTOMATIC CHILDREN Example of preparations for prevention units daily Purchase OTC Abidec, Dalivit, Baby D drops and Healthy Start Vitamins- (Healthy Start- free if eligible) 1 month -12 years 400 units daily Purchase OTC preparations e.g. Abidec, Dalivit, Boots High Strength Vitamin D, Ddrops, Holland & Barrett SunviteD3, Dlux oral spray, SunVit D3 and Vitabiotics tablets (Healthy Start Vitamins free to eligible children up to their 4 th birthday.) 12 years 18 years units daily Purchase OTC preparations e.g. Abidec, Dalivit, Boots High Strength Vitamin D, Ddrops, Holland & Barrett SunviteD3, Dlux oral spray, SunVit D3 and Vitabiotics tablets Management Risk factors but no symptoms No investigations, give diet and lifestyle advice plus prevention preparation No investigations, give diet and lifestyle advice plus prevention preparation No investigations, give diet and lifestyle advice plus prevention preparation 2.3 Who should be tested for vitamin D deficiency? Routine testing of vitamin D levels is NOT recommended. Vitamin D deficiency or insufficiency should be considered and checked for ONLY if patients are symptomatic, have other risk factors and where other causes for symptoms have been excluded. 4

5 2.4 Symptoms of vitamin D deficiency in children; Infants Seizures Tetany Cardiomyopathy Children Aches and pains long standing of more than 3 months Myopathy causing delayed walking Rickets with bow legs wide range of related skeletal defects, swelling of costochondral junctions. Knock knees Poor growth and muscle weakness Fractures following minor trauma Adolescents Aches and pains long standing of more than 3 months Muscle weakness Bone changes of rickets or osteomalacia Fractures following minor trauma 2.6. Referral to Hospital Paediatrician; ALL children under 2 years with symptoms of vitamin D deficiency Children with suspicion of malabsorption, renal and hepatic disease Any child with skeletal deformities/short stature or orthopaedic abnormalities related to rickets Failure to respond to treatment after 3 months Unexplained severe deficiency if diagnosis is not certain 2.7. Investigations for symptomatic and at risk patients (refer to section 2.1 for children at risk of vitamin D deficiency) Vitamin D assay - routine vitamin D monitoring is not recommended unless child is symptomatic and at risk (see above for risk factors) Liver and renal function Full blood count- anaemia may be present if malabsorption Calcium level to exclude hypercalcaemia and obtain baseline for monitoring- if low vitamin D confirmed and calcium is raised or high-normal, check parathyroid hormone. Do not check parathyroid hormone routinely. Serum alkaline phosphatase levels Phosphate level 5

6 Children 2.8. Which children do we treat and how do we treat? Deficiency in children up to 18 years Age Serum 25- hydroxyvitamin D concentration Up to 6 months Less than 2 years refer to paediatrician- do not prescribe in primary care <30 nmol/l Deficiency Regimen Oral administration of colecalciferol (vitamin D3) is recommended Treatment dose: 3000 units daily for 8 weeks Prescribe colecalciferol 3000 units/ml liquid Then: Long term maintenance dose: 0 month to 6 months of age: units daily. Purchase OTC preparations and give advice on diet and lifestyle (Healthy Start Vitamins free if eligible). 6 months to 12 years Less than 2 years refer to paediatrician- do not prescribe in primary care <30 nmol/l Deficiency Treatment dose: 6000 units daily for 8 weeks, Prescribe colecalciferol 3000 units/ml liquid If Adherence issues 25,000 units every 2 weeks for 6 weeks, prescribe colecalciferol as InVita D3 25,000 units /ml Oral Solution. If ORAL therapy not appropriate Intramuscular injection 1x 150,000 international units is given as a single dose. Refer to hospital paediatrician if clinical response is not achieved after 3 4 months as a second treatment dose may be required. Then: Long term maintenance dose: units daily. Purchase OTC preparations and give advice on diet and lifestyle. (Healthy Start Vitamins free, if eligible, up to 4 th birthday) years <30 nmol/l Deficiency 10,000 units daily for 8 weeks prescribe colecalciferol capsules or If adherence issues: 25,000 units every 2 weeks for 6 weeks, prescribe colecalciferol as InVita D3 25,000 units /ml Oral Solution. Higher doses can be used in certain population of people please refer to pharmacist for advice. All ages All ages nmol/l Insufficiency >75 nmol/l Healthy If ORAL therapy not appropriate Intramuscular injection 1 x 300,000 international units is given as a single dose. Refer to hospital paediatrician if clinical response is not achieved after 3 4 months as a second treatment dose may be required. Then: Long term maintenance dose: units daily Purchase OTC preparations and give advice on diet and lifestyle Long term maintenance only, dose according to age as above: Purchase OTC preparation and also diet and lifestyle advice. Long term over the counter maintenance only according to age as above and also advise diet and lifestyle advice. 6

7 RESCRIBING CONSIDERATIONS FOR USE OF LICENSED MEDICINES, UNLICENSED MEDICINES OR NON-MEDICINES (DIETARY OR NUTRITIONAL SUPPLEMENTS) Licensed products can be used for loading regimes and maintenance doses, and it is recommended that these products are used where appropriate. There is also a large variety of unlicensed medicines and supplements available. These products are not all subject to the same assurances of quality, safety and efficacy as licensed medicines. It is recognised that the licensed products/regimens may not be suitable for all patients and so prescribers may choose to prescribe an unlicensed product. Unlicensed prescribing Prescribers are reminded that the General Medical Council guidance requires a prescriber to only Consider unlicensed product if there is no suitable licensed alternative for the patient and that the prescriber is satisfied that there is an evidence base for prescribing. Currently there was no UK licensed higher dose product available for treatment in children until a new product that was launched in September InVita D3 25,000 IU/ml oral solution (colecalciferol manufactured by Consilient Healthcare has obtained a license in children at a dose 25,000 IU every 2 weeks for 6 weeks Licensed from birth. Please refer to SPC 7

8 Follow Up Investigation Investigations following treatment are ONLY recommended in secondary care therefore a referral to the hospital paediatrician should be made where mal-absorption and poor compliance with medication is suspected. Investigations in secondary care Adjusted serum calcium should be checked 1 month after completing the loading regimen or after starting vitamin D supplementation in case primary hyperparathyroidism has been unmasked. If the injection is used, close monitoring of serum and urinary calcium, phosphate and renal function is needed to avoid changes in serum calcium. References: 1. Vitamin D and Bone Health: a practical clinical guideline for patient management National Osteoporosis Society April Guide for Vitamin D in Childhood Royal College of Paediatrics and Child Health October NICE guidance

9 Appendix 1 Flow chart for adults with suspected Vitamin D deficiency TREATMENT Assess the need for treatment based on total serum (OHD) level nmol/l <30 nmol/l Deficiency nmol/l Insufficient nmol/l Healthy 75 nmol/l Optimal Oral colecalciferol Fultium D3 (licensed) 3200 units daily for 13 weeks Or Rapid correction regimen Oral colecalciferol InVita D3 (licensed) 2 x units/1 ml every week for 6 weeks Or If Adherence issues/oral preps not suitable Administer Intramuscular injection Colecalciferol units as a single dose Long term maintenance with OTC Start one month after high dose treatment if applicable Lifestyle Dietary Advice Lifestyle/Dietary Advice Purchase OTC preparation Lifestyle/Dietary Advice 9

10 Appendix 2( NB LESS THAN 2 YEARS REFER TO PAEDIATRICIAN- DO NOT PRESCRIBE IN PRIMARY CARE) Flowchart for children with suspected Vitamin D deficiency TREATMENT Assess the need for treatment based on total serum (OHD) level nmol/l <25 nmol/l Deficiency nmol/l Insufficient >50 nmol/l Healthy Less than 6 months Colecalciferol liquid 3000 units OD For 8 weeks 6 months -12 years Colecalciferol liquid 6000 units OD For 8 weeks years Colecalciferol capsules units OD For 8 weeks Lifestyle/Dietary Advice Purchase OTC preparation According to age Adherence issues 6 months -18 years 25,000 units every 2 weeks for 6 weeks, prescribe colecalciferol as InVita D3 25,000 units /ml Oral Solution Oral therapy not suitable 6 months-12 years Intramuscular injection 1x 150,000 international units Oral therapy not suitable years Intramuscular injection 1x 300,000 international units 10