National vitamin D guidelines
Guidelines on vitamin D supplementation have been published by the NOS. These have been endorsed by the Royal College of Nursing, Bone Research Society, British Dietetic Association, Paget's Association, International Osteoporosis Foundation, UK Clinical Pharmacology Association, Primary Care Rheumatology Society, Royal Pharmaceutical Society, British Orthopaedic Association and the Society for Endocrinology.
These guidelines do not address supplementation in pregnant women, although this is covered in NICE guidance.
The importance of vitamin D guidelines
Guidelines to ensure adequate vitamin D levels are important because in the UK we become vitamin D deficient every year between October and April. Many high-risk frail people are also housebound throughout the year. People who have had a previous skin cancer will have been advised not to sunbathe, and others may be on medications (such as amiodarone) that are a contraindication to sunbathing.
Rickets, a disease associated with Victorian times, is now returning, so efforts to combat the condition are needed. Furthermore, vitamin D repletion is important to ensure efficacy of bone-strengthening treatments in our ageing population, as is calcium repletion.
Most elderly patients have dietary deficiency of calcium either because they are trying to cut down their cholesterol, or are too poor to eat properly. The housebound/residential care home patients rarely get out, even when the sun occasionally shines. For drugs like denosumab and zoledronate it is often part of agreed protocols that the vitamin D level has to be > 50 nmol/L to give the drug. Simply by correcting vitamin D deficiency you can make people feel better, sometimes relieve myalgia (especially in patients on aromatase inhibitors), and improve muscle strength reducing risk of falls and fracture, as well as ensuring the efficacy of the active treatment.
The British National Formulary (BNF) now lists a variety of vitamin D formulations, alone or in combination with calcium. Many people don't like taking calcium + vitamin D tablets because they are too gritty, 'taste like chalk', 'are too sweet', or give constipation and/or headaches. Some patients stop taking calcium + vitamin D supplements due to fears about side effects including cardiovasular problems. Some research studies have suggested patients may have an increased risk of heart attack if they take high doses of a calcium supplement alone or calcium and vitamin D together although the incidence of heart attack is still low. The conclusions of other research, however, has found that taking calcium and vitamin D supplements does not increase risk of heart attack or stroke. The UK Medicines and Healthcare products Regulatory Agency (MHRA) looked at the research findings and recommended that doctors still need to ensure patients are getting sufficient calcium especially if they are taking osteoporosis drug treatment. For more information for you and your patients, download the NOS 'Calcium supplements and blood tests' factsheet.
There are some new high-dose vitamin D products (cholecalciferol or vitamin D3) listed in the BNF so that GPs can prescribe vitamin D3 alone on an FP10, to correct vitamin D deficiency (InVita D3 50,000 IU once a week for 6-8 weeks and re-check, or the 3,200 IU Fultium once daily for 6 – 8 weeks and re-check) or a maintenance dose (Fultium 800 IU once daily, or Invita D3 1400 – 2000 IU once a day). The advantage of this for our frail elderly population is the medication can go in the Nomad, so improving adherence, rather than an over-the-counter preparation which may be forgotten about.
It should be noted that Fultium D3 capsules were re-formulated in October 2014. The old formulation of 800 IU and 3200 IU capsules contained arachis oil so were not suitable for people with a peanut or soya allergy. The new formulations and the 20,000 IU capsules now contain maize oil instead. In case old formulations containing arachis oil are still available it would be important that the pack is checked before dispensing to a patient with a known peanut or soya allergy. InVita D3 contains olive oil.
It should also be noted that the vitamin D in both preparations is made from irradiation of lanolin from sheep's wool so may be unacceptable to vegans. Additionally, the gelatin capsule formulations of both preparations are made from animal products so would not be suitable for either vegetarians or vegans.
Why should GPs assess vitamin D deficiency?
Vitamin D is essential for musculoskeletal health. It is required for optimal mineral metabolism and the control of calcium and phosphate homeostasis, it promotes calcium absorption from the bowel, enables mineralisation of newly formed osteoid tissue in bone and plays an important role in muscle function. Rickets in children and osteomalacia in adults are the main manifestations of vitamin D deficiency. Less severe vitamin D deficiency may lead to secondary hyperparathyroidism, bone loss, muscle weakness, falls and fragility fractures in older people.
Who to test for vitamin D deficiency
Vitamin D testing should be prioritised to those patients where the outcome will alter clinical management:
- Patients with bone diseases that may be improved with vitamin D treatment
Correcting vitamin D deficiency is essential for patients with osteomalacia and is beneficial for patients with osteoporosis. This does not mean that patients with osteoporosis should undergo routine vitamin D testing. Calcium and vitamin D3 supplementation is common practice in those on treatment for osteoporosis, and testing vitamin D levels in patients where the decision has been made to co-prescribe is unlikely to change patient management.
- Patients with bone diseases, prior to specific treatment where correcting vitamin D deficiency is appropriate
Ensuring patients receiving potent anti-resorptive osteoporosis treatments (denosumab or zoledronate) are not vitamin D deficient before starting treatment is required to avoid the development of hypocalcaemia.
- 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 25-hydroxy vitamin D (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 vitamin D as part of their clinical and laboratory evaluation.
NICE Public Health Guideline. Vitamin D: Supplement Use in Specific Population Groups [PH56]
These guidelines were updated in May 2017 after publication of The SACN vitamin D and health report 2016 and cover vitamin D supplementation in the context of the general population. The guidance includes the following groups of people as being at-risk of vitamin D deficiency:
- All pregnant and breastfeeding women, particularly teenagers and young women
- Children under 3 years
- People over 65 years
- People who have low or no exposure to the sun. For example, those who cover their skin for cultural reasons, who are housebound or confined indoor for long periods
- People who have darker skin, for example, people of African, African-Caribbean and South Asian origin
NICE directs primary care practitioners to look specifically at Recommendation 8 of the guidance which is to ensure health professionals recommend vitamin D supplements. This includes recording vitamin D supplement use among at-risk groups whenever possible.
Who to treat
The recommended definition of deficiency made for adopting into UK practice is:
- Serum 25OHD
- Serum 25OHD of 30 – 50 nmol/L may be inadequate in some people
- Serum 25OHD > 50 nmol/L is sufficient for almost the whole population
Following measurement of serum 25OHD, consider:
- Fragility fracture, documented osteoporosis or high fracture risk
- Treatment with anti-resorptive medication for bone disease
- Symptoms suggestive of vitamin D deficiency
- Increased risk of developing vitamin D deficiency in the future because of reduced exposure to sunlight, religious dress code, dark skin, etc
- Raised parathyroid hormone levels
- Medication with anti-epileptic drugs or oral glucocorticoids
- Conditions associated with malabsorption
In patients whose tests show they have sufficient vitamin D levels (> 50 nmol/L) the recommendations are to give lifestyle advice on maintaining adequate vitamin D levels through safe sunlight exposure and diet. For more information, see the Initiation section of this resource.
How to treat vitamin D deficiency
The key aims of treatment are:
- Using adequate doses to ensure correction of vitamin D deficiency (to > 50 nmol/L)
- Timely reversal of the clinical consequences of vitamin D deficiency
- Avoiding toxicity
Oral vitamin D3 is recommended as the treatment of choice in vitamin D deficiency.
Where rapid correction of vitamin D deficiency is required, such as in patients with symptomatic disease or about to start treatment with a potent antiresorptive agent (zoledronate or denosumab), the recommended treatment regimen is based on fixed loading doses followed by regular maintenance therapy:
- a loading regimen to provide a total of approximately 300,000 IU vitamin D, given either as separate weekly or daily doses over 6 to 10 weeks
- maintenance therapy comprising vitamin D in doses equivalent to 800 – 2000 IU daily daily (occasionally up to 4,000 IU daily), given either daily or intermittently at higher doses.
Where correction of vitamin D deficiency is less urgent and when co-prescribing vitamin D supplements with an oral anti-resorptive agent, maintenance therapy may be started without the use of loading doses.
Monitoring patients after treatment
A month after a loading dose of vitamin D has been given, a calcium blood test is recommended to make sure a patient does not have primary hyperparathyroidism. This causes hypercalcaemia, which would be exacerbated by the high-dose vitamin D supplement.
Routine follow-up vitamin D blood tests are generally unnecessary unless vitamin D deficiency symptoms continue, a patient has malabsorption problems or it is likely they have not been taking the prescribed supplements. In some cases (for example before each intravenous (IV) zoledronate or denosumab dose) local Clinical Commissioning Group protocols may require vitamin D to be tested; check your local protocols for guidance relevant to your region.