Overview

Vitamin D 24'000 IU for Oral Intermittent Supplementation

Status:
Completed

Trial end date:
2020-05-31

Target enrollment:
0

Participant gender:
All

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

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Hospital, Basel, Switzerland

Treatments:

Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins

Criteria

Inclusion Criteria:

- vitamin D deficiency by serum level <50 nmol/l

Exclusion Criteria:

- hypercalcaemia