Safety and Bioefficacy of Vitamin D2 and Vitamin D3
Information source: Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin D Deficiency
Intervention: cholecalciferol (Dietary Supplement); ergocalciferol (Dietary Supplement); Placebo (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Ulrike Lehmann Official(s) and/or principal investigator(s):
Jutta Dierkes, Prof. Dr., Study Director, Affiliation: Institut für Agrar- und Ernährungswissenschaften
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 Details
Official title: Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
Primary outcome: change of 25-hydroxvitamin D
Detailed 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)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years
- healthy
Exclusion Criteria:
- supplementation of vitamin d and calcium
- hypercalcemia
- hypercalciuria
- chronical illness (diabetes, kidney diseases, cardiovascular diseases)
- serum-creatinine above 115 mmol/l
- pregnancy or breastfeeding women
Locations and Contacts
Additional Information
Starting date: January 2012
Last updated: October 7, 2012
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