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Vitamin D supplementation protocols: loading, injection, etc – RCT June 2014

Study Of Various Vitamin D3 Supplementation Protocols That Are Used In Community Practice For Treatment Of Hypovitaminosis D

Endo 2014 - Chicago: Poster Board, Session: SAT 0229-0266-Vitamin D Metabolism & Action
Pratibha Shahajirao Pawal, M.D, DM Endocrinology
T. N. Medical College & B.Y.L. Nair hospital, Mumbai, Mumbai
Pawal PS,Joshi AS,Lathia T,Mittal S,Sharma BR,Dalwadi PP,Bhagwat NM, Chadha MD, Varthakavi PK.

Introduction: Hypovitaminosis D is widely prevalent in India (70-90%). Different dosing protocols have been used for Vitamin D(VITD) supplementation; however there is no universally accepted regimen.

Objectives: Comparison of serial VITD concentrations attained with various VITD supplementation protocols in VITD deficient subjects.

Methods: 242 subjects were screened. 105 consenting subjects( age 20-60 years) with Hypovitaminosis D(VITD <16ng/ml) participated in the study and were randomized to receive 4 different supplemental regimens i.e. single dose 6lacIU orally, single dose 6lacIU intramuscular, 60000IU once weekly for 8 weeks and 2000IU daily for 8 weeks.

Outcome measures: Primary outcome measure was the serial serum VITD concentration attained. VITD, Parathyroid Hormone (PTH), calcium, phosphorus, alkaline phosphatase were monitored at baseline, 1,3,6,8 & 12 weeks of therapy.

Results: 66.5% subjects were found to be vitamin D deficient (<20ng/ml). Baseline VITD concentrations for Oral, IM, Weekly and Daily groups were 10.6±3.7; 9.7±4.5; 8.9±4.4 and 10.2±4.3 ng /ml respectively. VITD concentrations increased significantly in all groups at 3 weeks(P <0.001).
After 8 weeks, VITD concentrations for Oral, IM, Weekly and Daily groups were 34.6±9.4; 40.6±15.1 ; 40.2±13.9 and 24.7±7.7ng/ml respectively. VITD concentration decreased from 8 weeks to 12 weeks in all groups except in IM group which maintained steady increasing trend from 8wks to 12 wks.VITD level >100ng/ml was observed in 40% of subjects in oral group while none of other groups showed VITD >100ng/ml at all time points. All groups were compared with mean percentage increment in VITD concentration at different time points. Serum intact PTH was increased in only in 40% of subjects with VITD <16 ng/ml.

Conclusions:

  • Only IM mega dose group showed sustained increment of VITD concentration at 12 weeks without VITD toxicity or hypercalcaemia.
  • Only oral group had VITD levels >100 ng/ml(40%) without clinical manifestations of hypervitaminosisD .
  • Oral loading dose is adequate for maintaining VITD sufficiency only for duration of 3 months & need for resupplementation at 3 monthly interval.
  • Weekly group also showed decline in VITD sufficiency at 12 weeks indicates need for retesting and supplementation.
  • 2000IU daily is not adequate to achieve sufficiency in VITD deficient subjects.

Summary by VitaminDWiki

Dose 8 weeks
(end of dosing)
12 weeks
600,000 IU oral35 ng
600,000 IU injection40 ng 40% > 100 ng
60,000 IU weekly40 ng declined by 12 weeks
2,000 IU daily 25 ng 

See also VitaminDWiki

Overview Loading of vitamin D contains the following

If a person is, or is suspected to be, very vitamin D deficient a loading dose is typically given

  • Loading = repletion = quick replacement (previously known as Stoss)
  • Loading doses range in size from 100,000 IU to 1,000,000 IU of Vitamin D3
  • The size of the loading dose is a function of body weight - see below
    Unfortunately, some doctors persist in using Vitamin D2 instead of D3
  • Loading may be done as quickly as a single day, to as slowly as 3 months.
    It appears that spreading the loading dose over 4-20 days is a good compromise
  • Loading is typically oral, but sometimes by injection (I.M,)
  • The loading dose persists in the body for about 3 months
    The loading dose should be followed up with continuing maintenance
    Unfortunately, many doctors fail to follow-up with the maintenance dosing.
  • As about 1 in 300 people have some form of mild allergic reaction to vitamin D supplements,
    it appears prudent to test with a small amount of vitamin D before giving a loading dose
  • The causes of a mild allergic reaction appear to be: (in order of occurance)
    1) lack of magnesium - which can be easily added
    2) allergy to capsule contents - oil, additives (powder does not appear to cause any reaction)
    3) allergy to the tiny amount of D3 itself (allergy to wool) ( alternate: D3 made from plants )
Loading dose: 133 studies at VitaminDWiki
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