1. health and fitness
2. disease

Management of Low Vitamin D Level: A Barnsley Guideline
(June 2013; for review May 2015)
Introduction
The objective of this guideline is to assist health care providers with current evidence-based practice
guidelines in reference to diagnosis and management of low vitamin D (VitD) level, in adults over the age
of 18 years.
Why vitamin D is important?
Vitamin D is essential for musculoskeletal health as it promotes calcium absorption from the bowel,
enables mineralisation in bone and plays an important role in muscle function. Severely low levels can
lead to osteomalacia or osteoporosis in adults, although there is currently no proven benefit in treating
asymptomatic patients. Less severe vitamin D deficiency or insufficiency may lead to secondary
hyperparathyroidism, bone loss, muscle weakness, falls and fragility fractures in older people.
Sources of Vitamin D
Over 80% of the body’s vitamin D supply is produced from the action of sunlight on the skin. Dietary
sources of vitamin D include oily fish, liver, meat, eggs, mushrooms and fortified cereal/milk. Dietary
sources can contribute to vitamin D status, but on their own, they are unlikely to sufficiently raise vitamin
D level.
Vitamin D testing
Vitamin D status is best assessed by measuring serum 25OHD (25-hydroxyvitamin D). Serum level of
other ‘bone health markers’ should also be checked such as Calcium, Parathyroid hormone (PTH),
Alkaline phosphatase (ALP), Phosphate and eGFR (or Creatinine clearance).
Vitamin D level below 30 nmol/L is termed deficiency. Level between 30–50 nmol/L may be insufficient
for some people. Level above 50 nmol/L is adequate for most people.
Routine Vitamin D screening is not advisable. Following recommendation should be followed Patient Group
1 Patients with bone diseases that a) may be improved with vitamin D treatment. Such as • Osteomalacia
• Insufficiency fracture
• Paget’s disease
or
b) where correcting vitamin D deficiency before starting
osteoporosis treatment is necessary. Such as • Unexpectedly low bone mineral density
• Bone mineral loss while on osteoporosis treatment
• treatment with a potent antiresorptive agent such as
Zoledronate, Denosumab or Teriparatide
2 Patients with musculoskeletal symptoms as chronic aches
and pains that could be attributed to vitamin D deficiency
3 Asymptomatic individuals at higher risk of developing
vitamin D deficiency (‘at risk’ group)
4 Asymptomatic healthy individuals without any risk factor
Recommendation
Testing of 25-OHD level is
recommended
(Routine testing may not be
necessary in patients with
fragility fracture, where a
Vitamin D supplement is
empirically prescribed in
addition to an oral
osteoporosis treatment).
Testing of 25-OHD level is
recommended
Routine testing is not
recommended
Testing not recommended
Who is at risk of developing Vitamin D deficiency?
An individual who has one or more of the following risk factor(s) (‘at risk’ group):
• Age above 65 years
• Institutional care or housebound
• Black and ethnic minority patients with darker skin
• Pregnant or breastfeeding woman
• Routine covering of face or body or routine use of sun screen with SPF8 and above
• Vegan or vegetarian diet
• Intestinal malabsorption, liver or renal disease
• Drugs including anticonvulsants, cholestyramine, rifampicin, glucocorticoids, anti-retrovirals
Who should receive treatment?
Vitamin D status
Vitamin D Deficiency
(below 30 nmol/L)
Vitamin D Insufficiency
(level 30–50 nmol/L)
Adequate Vitamin D
(Level above 50 nmol/L)
Treatment recommendation
Treatment recommended
Treatment is ONLY advised in patients with the following:
• Increased risk of developing vitamin D deficiency in future
(‘at risk’)
• Symptoms suggestive of low Vitamin D level
• Fragility fracture, osteoporosis or high fracture risk
• Treatment with antiresorptive medication for bone disease
• raised PTH
No treatment required.
Reassurance and General advice only
Management of low Vitamin D level (1 mcg = 40 IU; 2.5nmol/l = 1ng/ml)
Key aims of treatment
•
•
•
Use adequate doses to ensure correction of vitamin D status (ideally >50 nmol/L)
Reverse the clinical consequences of low vitamin D level in a timely manner
Avoid toxicity (rare possibility)
Non-Pharmacological treatment: Lifestyle & General Advice
This information should be made available to all individuals.
• Diet provides, at most, 20% of daily requirements.
• Exposure to sunlight is the main source of vitamin D in most individuals
Aim to spend 20-30 minutes outdoors at least 3 times a week between April and October (this
increases to 3-10 times for dark pigmented skin)
Face and arms exposed without sunscreen
• Asymptomatic ‘at risk’ individuals should be advised taking a OTC Colecalciferol supplement 10
mcg (400 IU) daily or intermittently at higher equivalent dose as a prophylaxis (DH 2012).
• Patient >65years who are housebound or institutionalised or a faller should be prescribed Adcal D3
1 Tab BD or equivalent unless contraindicated (NICE CG21).
Pharmacological treatment
Oral Colecalciferol (Vitamin D3) is the preparation of choice. Some preparations, however, may
contain gelatine (bovine or porcine; non-halal) or arachis (peanut) oil. Hence, it may not be suitable for a
vegetarian or nut allergy (check manufacturer). Vitamin D2 (Ergocalciferol) injection should only be
used in those who cannot take oral colecalciferol for cultural, dietary, religious or medical reasons.
Clinicians should prescribe Colecalciferol preparation by brand name as prescribing generically may result in
expensive specials being supplied which could cost several hundred pounds a script.
The following Vitamin D3 preparations are available, and recommended for use in Barnsley:
•
•
•
•
Pro D3 (Synergy Biologics) capsule (marketed as nutritional supplement), variety of strengths
available (brand of choice within primary care) – doesn’t contain peanut oil or gelatine. Suitable for
muslims (halal), Kosher, vegetarians or patients with nut allergy. www.ProD3.co.uk
Dekristol 20,000 IU capsule (Unlicensed) – contains gelatine and peanut oil (BHNFT only).
Fultium D3 (Internis) 800 IU capsule (licensed; on prescription only) – contains gelatine and peanut
oil. Maximum licensed dose is 4 capsules a day. Suitable for ‘monitored dosage system’.
Generic Colecalciferol – AVOID. Script could cost hundred to thousand pounds.
Various other brands are available ‘over the counter’ (OTC) and self-purchase should be encouraged for
asymptomatic individuals at higher risk of developing vitamin D deficiency (‘at risk’ group).
Treatment of low Vitamin D level is based on fixed-loading doses and maintenance therapy.
For those patients who require a liquid formulation the following preparations may be considered:-
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Vigantol® (colecalciferol) oil 20,000 IU/ml
10ml Available from Mawdsleys (Tel:
01302 553 000)
ColeVit D3® (colecalciferol) solution 3000
IU/ml (30ml and 100ml)
Available from Sterling Pharmaceuticals
Ltd (Tel: 0845 170 5566)
D Lux spray 3000 IU (colecalciferol per
spray) 100 sprays
Available from www.betteryou.uk.com
Pro D3 Cholecalciferol (Vitamin D3)
Liquid drops
Liquid
Liquid Forte
£7.25*
£20.00* (30ml)
£33.50* (100ml)
£7.95*
100 IU per drop
2000 IU/ml,
2000 IU/ml
3000 IU/ml
£9.80* ( 20ml)
£16.80* ( 50ml)
£22.50* ( 100ml)
£18.90* ( 50ml)
Does not have UK marketing
authorisation. Manufactured in
Germany.
Does not have UK marketing
authorisation.
Manufactured as a special by
Sterling Pharmaceuticals
Does not have a UK marketing
authorisation. Marketed as a
nutritional supplement
Does not have a UK marketing
authorisation. Marketed as a
nutritional supplement
*Prices as at April 2013, MIMS and respective manufacturer’s as listed above
Loading dose and Maintenance dose therapy
•
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 or
Teriparatide), the recommended treatment regimen is based on fixed loading doses followed by
regular maintenance therapy.
•
Where correction of vitamin D deficiency is less urgent and when co-prescribing Calcium and
Vitamin D supplements with an oral antiresorptive agent, maintenance therapy may be started
without the use of loading doses.
Treatment regimen: Loading dose therapy (Total of approximately 300,000 IU)
•
•
ProD3 / Dekristol 20,000 IU capsule, two given weekly for 7 weeks (280,000 IU)
Fultium D3 800 IU Capsule, four given daily for 3 months (approx 290,000 IU)
or
Treatment regimen: Maintenance therapy (1 month after loading) – given long term
800 to 2000 IU (occasionally up to 4,000 IU) daily or intermittently at a higher equivalent doses
•
•
•
ProD3 capsule 10,000IU, three to six capsules (30,000 – 60,000 IU) given once a month
Fultium D3 800 IU capsule – one to three capsules (800 – 2400 IU) daily
Kalcipos D (Calcium 500mg and Colecalciferol 800IU)1-2 tablet twice daily (if calcium
supplementation is also required).
Note: a dose of Kalcipos D above one tablet daily is outside of the license
or
or
Treatment monitoring
Aims
•
•
•
detect those who remain deficient after loading
detect those who become deficient during maintenance
detect those in whom vitamin D therapy uncovers sub-clinical primary hyperparathyroidism
Tests required
1. Adjusted serum calcium: 1 month after completing the loading regimen
2. Serum Vitamin D (25OHD) at 6 months. Routine monitoring is unnecessary but may be
appropriate in patients with symptomatic vitamin D deficiency or malabsorption and where poor
compliance with medication is suspected.
Vitamin D toxicity
•
•
•
•
European Food Safety Authority (EFSA) = upper limit of 4000 IU (100 µg) a day (or equivalent) is
safe for adults and children over 11 years of age
Vitamin D intake below 10,000 IU/day (or equivalent) is not usually associated with toxicity
Toxicity as defined by hypercalcaemia is not seen with a level below 500 nmol/L
Yearly high-dose vitamin D is ineffective and may cause increased risk of fracture
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Indications for specialist referral
•
•
•
•
Atypical clinical manifestations, renal stones, hypercalcaemia
Lack of clinical response to 2 courses of loading Vitamin D therapy (exclude non-compliance)
Chronic renal impairment (eGFR <35 ml/min)
Secondary causes – malabsorption, liver disease, renal disease, lymphoma, metastatic cancer,
Parathyroid disorders, sarcoidosis and tuberculosis.
Special situations
Pregnant and breastfeeding women
All pregnant and breastfeeding women are recommended to receive vitamin D 400 IU (10mcg) per day
(DOH 2012). In Barnsley, this is provided through the Health Start Vitamins. Please visit
www.healthystart.nhs.uk for further information.
Vitamin D should be measured ONLY on the basis of risk factor and clinical symptom. Low level should
be treated as in the non-pregnant state; however, maximum dosing of Colecalciferol is 4000 IU daily
during pregnancy. High intermittent dosing is not advised.
Drug induced vitamin D deficiency
If the patient is taking drugs that accelerate Vitamin D metabolism or if there are concerns regarding
absorption, then, higher doses may be required. The Medicines and Healthcare Regulatory Agency
(MHRA) have advised that patients on long-term anticonvulsant therapy require vitamin D
supplementation 400 IU daily as a prophylaxis.
Intestinal malabsorption / Chronic liver disease
Vitamin D deficiency in these situations should be treated with 2-3 times higher doses of
pharmacological vitamin D. Patient may require injectable preparation.
Patients with renal impairment
1-hydroxylation of Vitamin D is impaired in renal impairment. Hence, patients with eGFR 35 -50 ml/min
may require higher doses of Vitamin D supplementation. If eGFR is below 35, patient will require
Alfacalcidol or Calcitriol (Specialist initiation only).
Primary hyperparathyroidism and Vitamin D deficiency
These patients should be treated as needed and serum calcium should be monitored.
References
1. Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management, National
Osteoporosis Society, UK (April 2013)
2. Chief Medical Officers, England, Wales and Ireland. Vitamin D – advice on supplements for at risk
groups (Feb 2012)
3. Antiepileptics: adverse effects on bone. Drug Safety Update, Vol 2 issue 9: 2 (April 2009)
4. The National Diet & Nutrition Survey: adults aged 19 to 64 years. A survey carried out in Great
Britain on behalf of the Food Standards Agency and the Departments of Health by the Office for
National Statistics and Medical Research, UK. Volume 4 (2004)
Guideline authoring group
SWYPFT:
BHNFT:
Dr. Pravin Jha (Chief author & Cons Geriatrician)
Prof. A. O. Adebajo (Cons Rheum.), Dr. Simon Lee (Cons Geriatrician), Dr. Z. Merza (Cons Endo.),
Dr. Ann Straffen (Cons Biochemistry), Gillian Smith (Lead Pharmacist)
NHS Barnsley CCG:
Deborah Cooke (Lead Pharmacist)
Updated in June 2013 by Dr. Sangeeta Ray, Speciality doctor and Dr. Pravin Jha, Consultant Physician (June 2013)
Ratified by the Area Prescribing Committee - 9October 2013
For further information, Contact : Dr. Pravin Jha, Consultant Geriatrician,
Mount Vernon Hospital, Barnsley S70 4DP. Tel 01226 43 3387. Email: [email protected]
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