Vitamin D 24'000 IU for Oral Intermittent Supplementation
Status:
Completed
Trial end date:
2020-05-31
Target enrollment:
Participant gender:
Summary
Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with oral
supplementation. National guidelines recommend the administration of 800 IU cholecalciferol
daily for an effective treatment, especially during the winter (poor sun exposition).
Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible.
Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or
alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment
between newly developed soft capsules and monthly solution (primary outcome), and to evaluate
the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per
day) on the achievement of optimal values >75 nmol/l (secondary outcome). The investigators
will use newly developed soft capsules and alcoholic solution, which are commercially
available in Switzerland.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins