1. No category

NHS FORTH VALLEY
Investigation & Treatment of
Vitamin D deficiency in Adults
25/07/2013
Date of First Issue
25/07/2013
Approved
25/07/2013
Current Issue Date
25/07/2015
Review Date
Version 1
Version
Yes
01/07/2013
EQIA
Fiona Allan, Primary Care Pharmacist
Author / Contact
Group Committee – ADTC
Final Approval
This document can, on request, be made available in alternative formats
Version 1
25th July 2013
UNCONTROLLED WHEN PRINTED
Page 1 of 9
Consultation and Change Record
Contributing Authors:
Fiona Allan, Primary Care Pharmacist
Dr Linda Buchanan, Consultant Endocrinologist
Dr Chris Kelly, Consultant Endocrinologist
Consultation Process:
Primary Care Prescribing Group
Acute ADTC
FV Renal Physicians (Dr Scott Morris)
FV Dieticians (Jane Sillars, Pamela McIntosh)
Area Drug and Therapeutics Committee
Distribution:
NHS FV Intranet
Change Record
Date
Version 1
Author
Change
25th July 2013
UNCONTROLLED WHEN PRINTED
Version
Page 2 of 9
Scope:
This guideline applies to people over 16 years of age. This guideline is not intended to
serve as a standard of medical care or be applicable in every situation. Decisions regarding
the treatment of individual patients must be made by the clinician in light of that patient’s
presenting clinical condition and with reference to current good medical practice.
Version 1
25th July 2013
UNCONTROLLED WHEN PRINTED
Page 3 of 9
Investigation & Treatment of Vitamin D deficiency in Adults: Algorithm
Does the patient have ≥1 symptom of vitamin D deficiency?
• widespread bone pain or tenderness or myalgia (no mechanical injury)
• proximal muscle weakness
• gait abnormalities
AND/OR
Does the patient have ≥1 risk factor for vitamin D deficiency?
• vegan/vegetarian
• liver/renal disease
• intestinal malabsorption e.g. coealiac disease, crohn’s disease, gastrectomy,
• medication such as anticonvulsants, cholestyramine, rifampicin, antiretrovirals, glucocorticoids
• obesity/bariatric surgery
ƒ learning disability
No
Vitamin D testing not
routinely required.
See notes 1, 2 on
supplementation of
‘at risk’ groups
without symptoms
Yes
If other causes for symptoms have been excluded, take blood for the following:
2+
25 (OH) Vitamin D, Ca
4+
, PTH, LFTs, PO , U+Es, FBC [see 4]
Yes
Box 3: Does the patient have any of the following?
Hypercalcaemia [see 6]
Pregnant [see 7]
Primary Hyperparathyroidsim [see 5]
CKD 4 or 5 [see 4]
Severe liver disease
Sarcoidosis
Metastatic bone disease
Malabsorption
Yes
If pregnant [see 7].
Otherwise contact
relevant specialist.
No
Proceed to treatment based on vitamin D level
Less than 25nmol/L = deficient
Give colecalciferol 4000IU as Desunin 5 tablets daily
for 12 weeks. [see 8,9 first]
Then advise OTC maintenance 800 IU daily [11].
Give lifestyle advice [1, 2]
If hypocalcaemic consider giving an additional
1000mg calcium (Sandocal is on formulary and
delivers this dose)
25 to 50nmol/L =
insufficient
Maintenance therapy
with 800 IU OTC daily
[11] and give lifestyle
advice [1, 2].
>50 nmol/L =sufficient but
consider time of year [see
12] may need OTC
supplementation with 400
IU daily [11]
Give Lifestyle advice [1, 2]
Check calcium 8-12 weeks after starting Vitamin D, for all patients, unless symptoms of hypercalcaemia [see
9] dictate sooner.
Check calcium at 4, 8 and 12 weeks if risks of hypercalcaemia are higher than average e.g. baseline raised
PTH, CKD, active TB, on thiazide diuretics in combination with calcium supplements, on digoxin.
Stop any calcium supplementation when calcium levels are within reference interval.
If PTH or Alk Phosp were abnormal prior to starting vitamin D repeat at 12 weeks. [14]
The re-checking of Vitamin D levels post treatment are not routinely recommended unless on the advice of a
specialist, for patients with the medical conditions outlined in box 3 [13].
Version 1
25th July 2013
UNCONTROLLED WHEN PRINTED
Page 4 of 9
Investigation & Treatment of Vitamin D deficiency in Adults: Notes to Accompany
Algorithm
1. Those in a risk group:
ƒ
all pregnant and breastfeeding women,
ƒ
infants and young children under 5 years of age,
ƒ
older people aged 65 years and over,
ƒ
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 indoors for long periods,
ƒ
people who have darker skin, for example people of African, African-Caribbean and
South Asian origin, because their bodies are not able to make as much vitamin D,
without symptoms should be given lifestyle advice (see below) and take a daily
supplement. See CMO letter http://www.scotland.gov.uk/Resource/0038/00386921.pdf
2. Lifestyle advice: 10-20 minutes unprotected sun exposure between 11 and 3pm (April
to September). This level of exposure is considered safe but skin should be covered
before it becomes red. This will be insufficient for those with darker skin. Family
members are likely to have similar risk -give lifestyle advice.
Only a small amount of vitamin D is acquired from food. Dietary sources include oily
fish such as trout, salmon, mackerel, herring, sardines, fresh tuna, cod liver oil and
some breakfast cereals (check individual brands).
3. Women and children from families who are eligible for the Healthy Start scheme can
get free multivitamin supplements which contain the recommended levels of vitamin D
in the form of tablets for women and drops for children. Healthy Start Vitamins are
available within NHS Forth Valley at various Health Centres and through Health
Visitors. This complete list is available at
http://www.nhsforthvalley.com/__documents/healthservices/healthpromotion/nutrition/healthy_start_vitamin_leaflet_02.02.121.pdf
4. Check FBC because there is often co-existing anaemia. Those with CKD 4 or 5 may
not respond to colecalciferol and should be referred to renal, where alfacalcidol is likely
to be recommended (dose as per specialist advice). PTH samples must be received by
the laboratory within 4 hours of being taken and a sample for calcium analysis must be
sent at the same time.
Version 1
25thJuly 2013
UNCONTROLLED WHEN PRINTED
Page 5 of 9
5. In vitamin D deficiency, serum Ca may be low or, because of secondary
hyperparathyroidism, may be normal. Serum phosphate usually decreases, and
alkaline phosphatase usually increases. Serum PTH may be elevated, depending on
severity of deficiency.
Calcium
Normal
Low
PTH
normal
Raised
Vitamin D
<25
<25
Diagnosis
vitamin D deficiency
vitamin D deficiency
with secondary
hyperparathyroidism.
Normal
raised
PTH
low Vit D
Low
Low/
normal
May have primary
hyperparathyroidism
masked by co-existent
vitamin D deficiency or
vitamin D deficiency
with secondary
hyperparathyroidism.
Hypoparathyroidism .
Action
Vitamin D replacement
Vitamin D replacement,
may need some initial
calcium too. Consider
Mg2+ check.
Treat vitamin D
deficiency. Check
calcium and PTH. If
calcium rises, refer to
endocrine. If PTH
remains elevated see
14.
Refer to endocrine.
Consider Mg2+ check.
6. Seek specialist advice before giving treatment doses of vitamin D in those with
hypercalcaemia.
7. Vitamin D deficiency in pregnancy: immediately start colecalciferol (Desunin) 800iu
daily and seek specialist advice. There is debate regarding high dose supplementation
in pregnancy. The baby is at high risk of deficiency particularly if breast fed and should
receive supplementation see Prescriberfile July & October 2012
http://staffnet.fv.scot.nhs.uk/wp
content/uploads/2012/12/Prescriberfile_July_2012_Final.pdf
http://staffnet.fv.scot.nhs.uk/wpcontent/uploads/2012/12/Prescriber_Oct_2012_Final.pdf
8. There are currently two licensed, SMC approved products containing colecalciferol
800iu: Desunin and Fultium D3. Based on current prices (MIMS April 2013), both
products cost £3.60 for 30 caps/tabs. Desunin has been chosen as the product of
choice within NHS FV for the following reasons:
•
it is not contraindicated in peanut or soya allergy (Fultium is);
•
it is suitable for vegetarians as it is a tablet formulation (Fultium D3 is a
capsule containing gelatin of bovine origin);
•
it can be crushed and therefore is a useful alternative where oral
administration is difficult;
•
it is licensed up to a maximum dose of 5 tablets daily = 4000iu/day of
colecalciferol (thus providing the same cumulative treatment dose of vitamin
D over 12 weeks – 336,000iu - as endorsed in the Endocrine Society’s
Vitamin D guideline1). Fultium D3 is only licensed up to a maximum dose of
4 capsules daily (=3200iu/day of colecalciferol).
Patients requiring higher daily doses of vitamin D (on advice of a specialist *) than are
accessible via these two products may require the sourcing of an unlicensed product.
Version1
25thJuly 2013
UNCONTROLLED WHEN PRINTED
Page 6 of 9
Community pharmacists are advised to follow the standard FV process for accessing
the most cost-effective ‘special’ formulation for these patients. This may result in an
initial delay in obtaining the product.
http://www.communitypharmacy.scot.nhs.uk/documents/nhs_boards/forth_valley/SPE
CIAL_FORMULATIONS_AND_UNLICENSED_PRODUCTS_IN_PRIMARY_CARE_D
ec2012_Final_Version2.pdf
The following document on available products to delivery varying doses of vitamin D
may be useful.
http://www.medicinesresources.nhs.uk/upload/documents/Communities/SPS_E_SE_E
ngland/Vitamin_D_product_availability_Jan_2013_V1_FINAL.pdf
* patients with malabsorption syndromes may require doses 2-3 times higher than
normal, licensed doses of vitamin D for both the treatment and maintenance phase of
therapy (i.e. 6000-10000 IU/day for treatment, followed by 3000-6000 IU/day for
maintenance). These doses are only for initiation of advice of a specialist.
9. All patients receiving vitamin D treatment doses or calcium should be advised of the
signs of hypercalcaemia, namely; nausea, vomiting, abdominal pain, headache,
apathy, polyuria, anorexia. Patients on thiazides may be more likely develop
hypercalcaemia.
10. Following treatment of deficiency, maintenance treatment should be continued and
probably be lifelong. Symptoms will take approximately 8 weeks to improve following
treatment of deficiency.
11. It is the view of NHS Forth Valley that once the initial deficiency has been corrected
that maintenance treatment should not be prescribed on a GP10 prescription, but
rather patients should be advised to purchase a suitable OTC food supplement
(containing 400-800 IU of vitamin D daily as per flowchart).
The exception to this rule are patients with an underlying medical condition –
see box 3 – resulting in vitamin D deficiency, under the care of specialists.
OTC supplements are available, in varying strengths/formulations, via pharmacies,
supermarkets and healthfood shops. 10 micrograms of ergocalciferol (vitamin D2) or
colecalciferol (vitamin D3) = 400 IU of vitamin D.
Some examples of suitable products (containing 400 or 800 IU vitamin D as a single
agent) include: Pro D3 range – includes 400 iu tablet and drops 100iu per drop; Health
Aid vitamin D3 drops 5mcg (200iu); Solgar Vitamins – vitamin D softgels 400 iu;
Lamberts vitamin D tablets 400iu.
Supplements containing vitamin D3 (colecalciferol) are obtained from animal sources
(usually as a by-product of wool fat) and are not suitable for strict vegetarians. Vitamin
D2 (ergocalciferol) is obtained from plant sources and can be recommended.
If compliance is difficult, maintenance doses can be taken weekly eg 6,000 IU a week
(utilising one of the available 1000 IU supplements).
For patients who cannot take tablets, an oral food supplement spray is available called
DLUX in strengths of 400 IU, 1000 IU, 3000 IU per spray.
Version1
25thJuly 2013
UNCONTROLLED WHEN PRINTED
Page 7 of 9
NB If local availability of OTC supplements makes the procurement/purchase of
products containing the exact amounts of vitamin D recommended in these guidelines
difficult, it should be noted that local/national guidelines 1,2,3 on vitamin D consider
maintenance treatment with a long term vitamin D supplement at a dose range
between 800-2000IU/day to be acceptable and safe.
12. The time of year a sample has been taken should be taken into consideration in
interpreting borderline results. Results from the end of summer will be the highest that
patient will achieve all year and results at the end of spring will be the lowest. Patients
with low-normal levels at the end of summer may benefit from supplementation.
13. Testing for Vitamin D is undertaken by Glasgow Royal Infirmary (GRI). The method
used has changed and now measures 25(OH) vitamin D3 (colecalciferol). To measure
vitamin D following ergocalciferol treatment, 25(OH) vitamin D2, request analysis by
the previous method of mass spectrometry – contact biochemistry (0141-211-4362). A
vitamin D test costs approximately £15 (as of 2012, GRI undertook approx 40,000
vitamin D levels at a cost of £600,000 to NHS Scotland). Routine re-testing of
vitamin D levels (after initial deficiency is established) is not recommended, as
there are no recommended vitamin D target levels for people on vitamin D replacement
therapy. Requests for repeat vitamin D levels less than 1 year from the original request
(without a clinical explanation) will be automatically rejected by the laboratory.
Repeating a vitamin D level in known malabsorption patients 6 months after completing
a treatment dose is clinically justified.
14. Patients whose PTH does not return to within the reference interval following correction
of vitamin D status may have previously unsuspected primary hyperparathyroidism or
tertiary hyperparathyroidism due to prolonged stimulation of the parathyroids by severe
longstanding vitamin D deficiency. Patients whose PTH remains elevated should be
discussed with endocrinology.
References
1. The Endocrine Society’s Clinical Guidelines. Evaluation, Treatment and Prevention of
Vitamin D Deficiency: An Endocrine Society Clinical Practice Guideline. Journal of
Clinical Endocrinology & Metabolism, July 2011, 96 (7): 1911-1930. http://www.endosociety.org/guidelines/final/upload/final-standalone-vitamin-d-guideline.pdf
2. Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management.
April 2013. http://www.nos.org.uk/document.doc?id=1352
3. Vitamin D guidance. Barts and the London School of Medicine and Dentistry. Clinical
Effectiveness Group. January 2011. http://www.icms.qmul.ac.uk/chs/Docs/42772.pdf
Acknowledgement
NHS Forth Valley would like to acknowledge NHS Tayside for their permission in utilising
their Vitamin D guideline as the basis of this document.
Version1
25thJuly 2013
UNCONTROLLED WHEN PRINTED
Page 8 of 9
Publications in Alternative Formats
NHS Forth Valley is happy to consider requests for publications in other language or
formats such as large print.
To request another language for a patient, please contact 01786 434784.
For other formats contact 01324 590886,
text 07990 690605,
fax 01324 590867 or
e-mail - [email protected]
Version1
25thJuly 2013
UNCONTROLLED WHEN PRINTED
Page 9 of 9