drugset / Trial / NCT03141593

Oral Vitamin D Substitution Weekly or Monthly and Adherence

NCT03141593

Phase 4 Completed 97 enrolled University Hospital, Basel, Switzerland
RandomizedCrossoverOpen-labelTreatment

Summary

Vitamin D deficiency (defined as 25(OH)-vitamin D serum level \<50 nmol/l) is cured with supplementation by mouth. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Commercially available pharmaceutical forms are liquid in Switzerland (drops) and solid forms in Germany (tablets and capsules). Because therapeutic range of vitamin D3 is wide and toxicity is seldom reached, even after the consumption of 200'000 IU, and because the administration of 8 drops daily is inconvenient, weekly and monthly administrations of the cumulative amount (i.e., 5'600 IU weekly or 24'000 IU monthly) have been investigated. Both administration schedules are therapeutic equivalent. The study aims to investigate which form (liquid or solid) and which schedule (weekly or monthly) procure the highest adherence behavior with outpatients under polypharmacy i.e., with 4 or more medications daily. The investigators will use commercially available Swiss and German products.

Timeline

Start
2017-10-09
Primary completion
2018-10-31
Completion
2018-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cholecalciferol Other / unclassified 5600 iu Oral
Comparator Cholecalciferol Other / unclassified 20000 iu Oral
Comparator Cholecalciferol Other / unclassified 24000 iu Oral

Indications