Effect of Vitamin D Treatment on Fatigue
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|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|
|Actual Primary Completion Date :||May 2015|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|