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Clinical guideline Vitamin D — for adults Importance of vitamin D A significant proportion of the UK population have low vitamin D levels, which has resulted in a rising number of reported cases of rickets in children and osteomalacia in adults. This is of particular concern for all pregnant and breastfeeding women, young children, older people, black and ethnic minority groups, and those at risk of inadequate sunshine exposure. Pregnant women especially need to ensure their own requirement for vitamin D is met and to build adequate fetal stores for early infancy. Vitamin D deficiency impairs the absorption of dietary calcium and phosphorus, which can give rise to bone deformities in children, and bone pain and tenderness as a result of osteomalacia in adults. It is essential that everyone, especially those people most at risk, are aware of the implications of vitamin D deficiency and most importantly what they can do to prevent it. Risk factors for vitamin D insufficiency and deficiency Pigmented skin (non-white ethnicity) Lack of sunlight exposure Skin concealing garments or strict sunscreen use Multiple, short interval pregnancies Elderly or housebound Vegan / vegetarian Malabsorption e.g. inflammatory bowel disease, coeliac disease, pancreatic insufficiency. Use of anticonvulsants, rifampicin, cholestyramine, anti-retrovirals Sources of vitamin D The sun: Our body creates most of our vitamin D from modest exposure to direct UVB sunlight. Regular, short periods of UVB exposure without sunscreen during the summer months are enough for most people. However, some groups (see risk factors listed above) may not be able to get enough vitamin D in this way. In addition, those living at above 52° N latitude (the UK is at a latitude of 50–60° N) may not get enough vitamin D during the winter months. Diet: Food in the diet can also contribute to vitamin D levels, but the average daily intake is just 2–4 micrograms, and it is difficult to obtain enough vitamin D from diet alone. Food sources include: Oily fish (such as salmon, mackerel and sardines) Cod liver oil and other fish oils Eggs Meat Mushrooms Manufacturers also have to add it to all margarine and infant formula milk. Other manufacturers add it voluntarily to some breakfast cereals, soya products, some dairy products, powdered milks and low-fat spreads; however, this is often a minimal amount. Breastfed babies get their vitamin D from their mother’s breastmilk, which is one reason why it is important for pregnant and breastfeeding mothers to have adequate vitamin D levels of their own. Infant formula milk is fortified with vitamin D, so formula-fed infants get their vitamin D in this way. Vitamin D for adults – clinical guideline, v1 Approved by Medicines Clinical Guideline Subcommittee: April 2012 Principal Author: Rachael Pugh, NHS Wirral Review by: April 2015 Page 1 of 7 Prevention of vitamin D deficiency and insufficiency It is important that people who find it hard to get enough vitamin D from the sun and their diet take a vitamin D supplement. Specific groups who may benefit from vitamin D supplementation are listed in the table below: These guidelines below are taken from Department of Health recommendations People at risk of vitamin D deficiency Daily vitamin D supplement All pregnant and breastfeeding women. 400 International Units / day People who are not exposed to much sun, e.g. people confined indoors for long periods and those who cover their skin for cultural reasons 400 International Units / day People aged 65 years and over. Wirral guidelines recommend calcium and vitamin D supplements for frail elderly individuals who are housebound or care home patients (see elderly patients section below). 400 International Units /day ********* 1 microgram (mcg) is equivalent to 40 International units *********** Patients can be advised to buy over the counter vitamin supplements or prescribe Pro D3 (colecalciferol) 400 International Units capsules (nutritional supplement). Clinical features of vitamin D deficiency Muscle pain Proximal muscle weakness Rib, hip, pelvis, thigh and foot pain are typical Fractures Assessing the patient Patient characteristics Healthy, no risk factors, symptom free Risk factors only Risk factors AND clinical features Vitamin D for adults – clinical guideline, v1 Approved by Wirral Drug & Therapeutics Committee: April 2012 Advice and management No investigations required Lifestyle advice Lifestyle advice Consider long term preventative therapies Lifestyle advice Investigations Therapeutic intervention Long term preventative treatment Principal Author: Rachael Pugh, NHS Wirral Review by: April 2015 Page 2 of 7 Investigations Test Renal function tests (U&E, eGFR) Reason To exclude renal failure. See note below on renal patients To exclude hepatic failure Anaemia may be present if there is malabsorption To exclude primary hyperparathyroidism Liver function tests (including ALP) FBC TFTs (including parathyroid hormone) Calcium To exclude hypercalcaemia and provide a baseline for monitoring. Hypocalcaemia may indicate long standing vitamin D deficiency. Hypophosphataemia may indicate long standing vitamin D deficiency. To determine vitamin D status Phosphate 25-OH Vitamin D levels Measurement, status and management The most reliable way to determine vitamin D deficiency is by assay of serum 25‐hydroxyvitamin D (25(OH)D). Vitamin D level <25nmol/l Vitamin D status Deficient Health effect Rickets, Osteomalacia 25 -50 nmol/l Insufficient 50 – 75 nmol/l >75nmol/l Adequate Optimal Associated with disease risk Healthy Healthy Management High dose calciferol then long term maintenance treatment. Long term vitamin D supplements Lifestyle advice None Contraindications for vitamin D Patients with hypercalcaemia or metastatic calcification. When to refer to secondary care All children under 1 year Atypical biochemistry Deficiency due to malabsorption Liver disease Parathyroid disorders Sarcoidosis Tuberculosis Failure to respond to treatment after 3 months Lymphoma Renal disease Short stature Unexplained deficiency Vitamin D for adults – clinical guideline, v1 Approved by Wirral Drug & Therapeutics Committee: April 2012 Atypical clinical manifestations or biochemistry Focal bone pain Metastatic cancer Renal stones Skeletal deformity Unexplained weight loss Principal Author: Rachael Pugh, NHS Wirral Review by: April 2015 Page 3 of 7 Advice on prescribing vitamin D for adults Vitamin D is available as either oral ergocalciferol (vitamin D2) or oral colecalciferol (vitamin D3) and intramuscular (IM) ergocalciferol. Colecalciferol and ergocalciferol are considered to be bioequivalent and interchangeable. However, colecalciferol has been reported to raise serum vitamin D concentrations more effectively than ergocalciferol and is therefore the drug of choice. For a list of available preparations please see tables in appendix. N.B. Liquid ‘specials’ of vitamin D (unlicensed) should NOT routinely be prescribed for adults. Treatment regimes A) Treatment of deficiency (25-OHD <25nmol/l) - high dose calciferol followed by long term maintenance treatment Calciferol Dose 60,000 International Units Frequency Route Weekly Oral Length of Course 8-12 weeks 10,000 International Units Daily Oral 8-12 weeks Preparations ProD3 (colecalciferol) capsules 20,000 international units. This preparation has no product licence and is marketed as a nutritional supplement. ProD3 (colecalciferol) 10,000 International Units capsules. This preparation has no product licence and is marketed as a nutritional supplement. 300,000 One off IM N/A Ergocalciferol i.m. injection 7.5mg International dose (300,000 International Units ) per ml. Units This is currently unavailable until April 2012. Prescribe unlicensed alternative – colecalciferol 300,000 International Units im injection. * To convert International Units to micrograms of calciferol, divide by 40. B) Treatment of insufficiency (25-OHD: 25 - 50nmol/l) or long term maintenance after deficiency Calciferol Dose 400 - 1600 International Units. (Can increase to 2000 International Units if necessary) Frequency Route Daily Oral Length of Course Indefinite Preparations Patients can be advised to purchase over the counter vitamin D treatments (400 to 1,000 International Units calciferol daily). See table in appendix 1 for list of preparations. Or prescribe: Colecalciferol 800 International Units capsules (FultiumD3) daily. This product has a marketing authorisation and is licensed in the UK. Or if gelatin free / peanut oil free product required prescribe: ProD3 400 International Units capsules daily. Vitamin D for adults – clinical guideline, v1 Approved by Wirral Drug & Therapeutics Committee: April 2012 Principal Author: Rachael Pugh, NHS Wirral Review by: April 2015 Page 4 of 7 Elderly Patients The elderly are at increased risk of vitamin D deficiency due to a combination of factors including lower sun exposure and reduced capacity to generate vitamin D. Wirral guidelines for the management of osteoporosis recommend that calcium and vitamin D supplements should be prescribed routinely for frail elderly individuals who are housebound or care home patients. The recommended daily dose is Calcium 1 – 1.2g and vitamin D3 800 units which can be obtained by prescribing one of the following according to patient preference. • Adcal D3 or Adcal D3 dissolve (effervescent tablets) – 1 tablet twice daily • Calceos 1 tablet twice daily • Calcichew D3 Forte 1 tablet twice daily • Natecal D3 1 tablet twice daily • Calfovit D3 1 sachet once daily (granules to make liquid preparation) Renal Adult Patients Renal adult patients on dialysis requiring vitamin D for the treatment of secondary hyperparathyroidism, should be treated in accordance with the Bone Chemistry management in adult renal patients on dialysis Clinical Guideline. This will be initiated in secondary care. Renal adult pre-dialysis patients (CKD 3-5) requiring vitamin D for raised parathyroid hormone (PTH), should be treated with alfacalcidol. Please refer to Chart 2 in the Bone chemistry management for pre-dialysis adult patients (CKD stage 3-5) clinical guideline. Calcium and Vitamin D Preparations Generally (apart form the elderly who are housebound or in care homes) clinicians should avoid giving combined vitamin D and calcium preparations in the long term because the calcium component is unnecessary and unpalatable, reducing concordance. A recent meta-analysis has raised concerns about a possible modest increase in the risk of some cardiovascular events in postmenopausal women who use calcium and vitamin D supplements to prevent osteoporotic fractures. However, there are limitations to the data and no change to prescribing practice is currently recommended. Prescribers should consider the potential benefits and risks of using calcium and vitamin D for prevention of osteoporotic fractures on an individual basis in line with NICE guidance. Prescribers should consider offering these supplements to postmenopausal women who receive treatment for osteoporosis (e.g. with bisphosphonates), unless they are confident that the patient has an adequate calcium intake and is vitamin D replete. Intestinal Malabsorption These patients should be referred to secondary care. Vitamin D deficiency caused by intestinal malabsorption or chronic liver disease usually requires vitamin D in pharmacological doses. A suggested regime for adult patients would be to use ergocalciferol 300,000 International Units by intramuscular injection monthly for 3 months, followed by 300,000 IU by intramuscular injection once or twice a year. At the time of writing this licensed preparation is currently unavailable and is expected to become available from April 2012. In the meantime use colecalciferol injection 300,000 International Units by im injection (unlicensed preparation). Vitamin D for adults – clinical guideline, v1 Approved by Wirral Drug & Therapeutics Committee: April 2012 Principal Author: Rachael Pugh, NHS Wirral Review by: April 2015 Page 5 of 7 Monitoring Adults receiving high dose vitamin D therapy for deficiency Plasma calcium levels should be checked after 2 weeks and repeated if there are signs of hypercalcaemia (anorexia, nausea, thirst, polyuria, diarrhoea, confusion) At 3 months check calcium and 25-OH Vitamin D levels. Recheck calcium levels 4 weeks after any dose changes. N.B. Usual range for calcium is 2.13 - 2.63 mmol/l. Corrected calcium mmol/l = [(40-serum albumin) x 0.02] + serum calcium. Adults receiving low dose vitamin D therapy for insufficiency No routine monitoring is necessary for patients on long term maintenance vitamin D doses of up to 2000 International Units a day. References 1. Pearce SHS, Cheetham TD. Diagnosis and management of vitamin D deficiency. BMJ 2010; 340: 142‐147. 2. Department of Health Information Leaflet. Vitamin D an essential nutrient for all… but who is at risk of vitamin D deficiency? Important information for healthcare professionals. 2007. 3. UK Chief Medical Officers Communication. Vitamin D advice on supplements for at risk groups, 2 Feb 2012. Accessed via https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=1017 26 on 07.02.12 4. Consensus vitamin D position statement, Dec 2010. Accessed via http://www.nelm.nhs.uk/en/NeLM-Area/News/2010---December/17/ConsensusVitamin-D-position-statement/?query=vitamin+d&rank=44 on 01.06.11 5. Vitamin D deficiency and insufficiency – using appropriate available products – Updated document (November 2011). Accessed via http://www.nelm.nhs.uk/en/NeLM-Area/Other-Lib-Updates/Drug-DiscontinuationAnd-Shortage/Vitamin-D-product-availability/ on 24.01.12 6. British National Formulary 66, September 2011 7. Drug Safety Update Oct 2011 vol 5, issue 3: H1. 8. Pro D3 website http://www.prod3.co.uk/ accessed 07.02.12 Vitamin D for adults – clinical guideline, v1 Approved by Wirral Drug & Therapeutics Committee: April 2012 Principal Author: Rachael Pugh, NHS Wirral Review by: April 2015 Page 6 of 7 Appendix: Vitamin D preparations Please note: all prices are correct at the time of publication but may be subject to change. 1. RECOMMENDED PREPARATIONS FOR TREATING DEFICIENCY IN ADULTS Product Cost Dietary restrictions Licensing ProD3 (colecalciferol) capsules 10,000 International Units 20,000 International Units 30,000 International Units Available from AAH Pharmaceuticals, tel. 024 7643 2000 Suitable for vegetarians, muslims (halal), kosher and are gelatin free Does not have a UK marketing authorisation. Marketed as a nutritional supplement. Ergocalciferol i.m. injection 7.5mg (300,000 International Units) per ml £14.99 for 30 capsules x 10,000 International Units £19.99 for 30 capsules x 20,000 International Units; £24.99 for 10 capsules x 30,000 International Units 1ml ampoule = £8.50 2ml ampoule = £9.85 Suitable for vegans and it is gelatin free Pro D3 products are registered with NHSBSA Prescription Services and ingredient cost remuneration is fixed at the NHS prices shown. Product has UK marketing authorisation. Currently unavailable – available from April 2012. 2. RECOMMENDED PREPARATIONS FOR THE TREATMENT OF INSUFFICIENCY AND LONG TERM MAINTENANCE THERAPY IN ADULTS A wide range of vitamin D preparations, in varying strengths are available to buy over the counter (OTC) from health food shops and pharmacists. For patients not exempt from prescription charges these supplements are generally less expensive to purchase than to obtain on prescription. Where possible purchasing OTC should be encouraged. If purchasing OTC is not an option, Fultium D3 (colecalciferol) 800 International Units capsules which has a UK marketing authorisation, should be prescribed for treatment of insufficiency or maintenance therapy. If a gelatin-free preparation is required ProD3 (colecalciferol) 400 International Units capsules should be prescribed. This product does not have a UK marketing authorisation and is marketed as a nutritional supplement. It is available for community pharmacies to order via AAH (£4.99 for 30 capsules). Below are some examples of OTC colecalciferol supplements. These do not have a UK marketing authorisation and are marketed as nutritional supplements: Product Cost Dietary information Holland and Barrett Sunvite vitamin D3 10μg (400 International Units) tablets. Available for purchase only from Holland and Barrett 100 tablets = £3.24 Contains, gelatine and glycerin Boots Pharmaceuticals Vitamin D3 25μg (1000 International Units) tablets Available for purchase from Boots Nature’s Remedy Vitamin D3 25μg (1000 International Units) capsules. Available for purchase only from www.naturesremedy.co.uk Nature’s Remedy Vitamin D3 25μg (1000 International Units) tablets. Available for purchase only from www.naturesremedy.co.uk BioLife Vitamin D3 25μg (1000 International Units) chewable tablets Available only from www.lifestylenaturalhealth.co.uk Vitamin D for adults – clinical guideline, v1 Approved by Wirral Drug & Therapeutics Committee: April 2012 250 tablets = £7.59 90 tablets = £5.10 100 capsules = £7.99 250 capsules = £14.99 100 tablets = £6.99 200 tablets = £11.99 90 tablets = £9.98 Suitable for vegetarians Contains, gelatine and glycerin Suitable for vegetarians Suitable for vegetarians Gelatin, dairy, wheat and gluten free Principal Author: Rachael Pugh, NHS Wirral Review by: April 2015 Page 7 of 7