Primary objective
-Change in Fatigue Assesment Score (FAS) between the first visit (baseline) and 28 (+maximum
7) days after oral administration of 100 000 E vitamin D (Cholecalciferol).
Secondary objectives
- Effect of oral administration of vitamin D on serum vitamin D levels (25-Hydroxy-Vitamin
D = Colecalciferol), PTH, Calcium, and Phosphate as compared to placebo.
- Efficacy of vitamin D (Colecalciferol) administration on fatigue using the short
self-developed FCA-Test
- Safety of 100 000 E oral vitamin D (Colecalciferol) administration as compared to oral
placebo. Laboratoty parameters such as serum calzium and phosphate levels and the number
of adverse events compared to placebo will be used for safety monitoring.
- Efficacy of oral administration of vitamin D (Cholecalciferol) on plasma FGF-23,
Sclerostin and Klotho levels compared to placebo.
Phase:
Phase 3
Details
Lead Sponsor:
University of Zurich
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins