Effect of Vitamin D Treatment on Fatigue
|ClinicalTrials.gov Identifier: NCT02022475|
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : July 21, 2015
-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.
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Vitamin D Other: placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Peroral Vitamin D Versus Placebo on Self-reported Fatigue in Adults With Low 25-hydroxy-vitamin D Levels|
|Study Start Date :||December 2013|
|Primary Completion Date :||May 2015|
|Study Completion Date :||June 2015|
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
- Intraindividual change of Fatigue as quantified by FAS (δFAS) 28 (+maximum 7) days after administering Vitamin D3 (Cholecalciferol) [ Time Frame: 28 (+maximum 7) days ]
- 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 ]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 ]
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022475
|Clinic and policlinic for Inetrnal Medicine|
|Zürich, Switzerland, 8091|
|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|