Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- change of 25-hydroxvitamin D
Study Overview
Brief 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.
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
- Placebo group
- Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)
- Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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
Arms & Interventions
Placebo
Placebo for 8 weeks
Intervention: Placebo (Dietary Supplement)
Ergocalciferol
Ergocalciferol 2000 IU per day for 8 weeks
Intervention: ergocalciferol (Dietary Supplement)
cholecalciferol
Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks
Intervention: cholecalciferol (Dietary Supplement)
Outcomes
Primary Outcomes
change of 25-hydroxvitamin D
Time Frame: after 4 and 8 weeks of supplementation
Secondary Outcomes
No secondary outcomes reported
Investigators
Ulrike Lehmann
Principal Investigator
Martin-Luther-Universität Halle-Wittenberg