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Transcript
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