Effect of Vitamin D Treatment on Fatigue
-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).
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Peroral Vitamin D Versus Placebo on Self-reported Fatigue in Adults With Low 25-hydroxy-vitamin D Levels|
- Intraindividual change of Fatigue as quantified by FAS (δFAS) 28 (+maximum 7) days after administering Vitamin D3 (Cholecalciferol) [ Time Frame: 28 (+maximum 7) days ] [ Designated as safety issue: No ]
- Efficacy of oral administration of vitamin D on serum vitamin D levels (25-Hydroxy-Vitamin D = Cholecalciferol), PTH, Calcium, and Phosphate as compared to placebo. [ Time Frame: 28 (+maximum 7) days ] [ Designated as safety issue: No ]Blood samples will be drawn, urine samples will be taken prior to and 28 (+maximum 7) days after the vitamin D administration.
- Efficacy of vitamin D (Cholecalciferol) administration on fatigue using the short self-developed FCA-Test [ Time Frame: 28 (+maximum 7) days ] [ Designated as safety issue: No ]
Fatigue course assessment (FCA)
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- Fibroblast Growth factor 23, sclerostin and soluble Klotho levels before and 28 days after vitamin D administration [ Time Frame: 28 (+maximum 7) days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Cholecalciferol
100 000 units vitamin D3 single dose
Drug: Vitamin D
100 000 units oral vitamin D as 2 capsules 50 000 units each
Other Name: Cholecalciferol
Placebo Comparator: Placebo
2 placebo capsules will be applied as a single dose
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02022475
|Contact: Albina Nowak, MD||0041 44 255 1111 ext firstname.lastname@example.org|
|Clinic and policlinic for Inetrnal Medicine||Recruiting|
|Zürich, Switzerland, 8091|
|Sub-Investigator: Lukas Boesch, Postgraduate|
|Study Director:||Krayenbühl Pierre-Alexander, Dr||University Hospital Zürich, Department of Internal Medicine|
|Principal Investigator:||Albina Nowak, MD||University Hospital Zürich, Department of Internal Medicine|