The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3
Not Applicable
Withdrawn
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: cholecalciferolDietary Supplement: 25(OH)D
- Registration Number
- NCT01633658
- Lead Sponsor
- Creighton University
- Brief Summary
The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
- Detailed Description
Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Ten men and women in each group,
- aged 20-60.
Exclusion Criteria
- History of hypercalcemia,
- vitamin D supplement use > 800 IU daily,
- BMI > 30,
- gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,
- use of steroids in any form,
- anticonvulsants,
- antibiotics,
- acute illness, or
- vacation planned to "sunny climate"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D Cholecalciferol cholecalciferol A single dose of 2500 micrograms cholecalciferol 25(OH)D 25(OH)D A single dose of 625 micrograms 25(OH)D
- Primary Outcome Measures
Name Time Method Serum 25(OH)D response 28 days 25(OH)D will be measured at frequent time intervals over 28 days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Creighton University
🇺🇸Omaha, Nebraska, United States