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NCT02091219 · ClinicalTrials.gov registry record · Early Phase 1
Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function
A Early Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 35
- Enrollment target
NCT02091219 is a Early Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 35 participants.
The verdict
NCT02091219, a Early Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effects of two different forms of vitamin D supplements (vitamin D3 and 25-hyrdroxyvitamin D3 \[25(OH)D3\]) on vitamin D levels in the blood, and on markers of skeletal and immune health. This study is designed as a pilot study. A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12 Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a screening visit during which a medical history will be taken, a physical exam performed, a dietary questionnaire administered, and blood collected. The purpose of the screening visit is to identify vitamin D-deficient (25-hydroxyvitamin D \<20 ng/ml) individuals who are candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After initiating supplementation, study patients will return for follow-up visits at weeks 4, 8, and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as well as markers of skeletal and immune function. Participation in this study will therefore involve a total of 5 visits (1 screening visit, 1 randomization visit during which participants will receive their study supplements, 3 follow-up visits). After all data is collected, changes in vitamin D levels in the blood following supplementation with either vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance and immune function. Knowledge gained from this study may have a significant impact on how vitamin D status is defined, and how vitamin D repletion is administered.
Interventions
- DRUG Vitamin D
- DRUG 25(OH)D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2014-06 |
| Est. Completion | 2019-12-07 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02091219
The ClinicalTrials.gov registry entry for NCT02091219 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vitamin D is the first listed.
NCT02091219 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02091219 about?
NCT02091219 is a clinical study titled "Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function". The purpose of this study is to compare the effects of two different forms of vitamin D supplements (vitamin D3 and 25-hyrdroxyvitamin D3 \[25(OH)D3\]) on vitamin D levels in the blood, and on markers of skeletal and immune health. This study is designed as a pilot study. A multi-ethnic cohort of 48...
What is the current status of trial NCT02091219?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 35 participants. The study started on 2014-06. Estimated completion is 2019-12-07.
What interventions are being tested in trial NCT02091219?
The interventions under investigation include: Vitamin D (DRUG), 25(OH)D3 (DRUG).
Who is sponsoring clinical trial NCT02091219?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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