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Safety and Bioefficacy of Vitamin D2 and Vitamin D3

Vitamin D Deficiency Clinical Trial

Official title:
Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers

Clinical Trial Summary

The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.

Clinical Trial Description

Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells.

Groups/Cohorts Assigned Interventions

1. Placebo group

2. Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)

3. Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule) ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01503216
Study type Interventional
Source Martin-Luther-Universität Halle-Wittenberg
Contact
Status Completed
Phase N/A
Start date January 2012
Completion date May 2012
View Details
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