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NCT02802449 · ClinicalTrials.gov registry record · NA
To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
A NA study, sponsored by Charles Drew University of Medicine and Science.
- Completed
- Registry status
- NA
- Development phase
- 330
- Enrollment target
NCT02802449: Completed NA study, sponsored by Charles Drew University of Medicine and Science.
NCT02802449 is a NA study that has completed, run by Charles Drew University of Medicine and Science. The registered enrollment target is 330 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02802449, a NA study, has completed, sponsored by Charles Drew University of Medicine and Science.
- COMPLETED
- Registry status
- NA
- Development phase
- 330 participants
- Enrollment target
Study Summary
Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive, African-American participants will be enrolled in a 8 week study to assess the effect of two administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical, biologic and genetic factors. The investigators anticipate that at least 300 participants will complete this study. Written, signed and dated informed consent to participate in the study will be given by the participant or a legally acceptable representative, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related activities/procedures. The original signed and dated consent will be kept in the subject's research file and a copy given to the subject. A copy will also be placed in their medical record.
Primary Outcome
Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-
Interventions
- DRUG Placebo
- DRUG 25 Hydroxy- Vitamin D3 [25 (OH) D3]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2013-09 |
| Est. Completion | 2018-07 |
| Phase | NA |
What the finished NCT02802449 record still lists
NCT02802449 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02802449 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02802449 about?
NCT02802449 is a clinical study titled "To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans". Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive, African-American participants will be enrolled in a 8 week study to assess the effect of two administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical, biologic and genetic factors. The i...
What is the current status of trial NCT02802449?
This trial is currently completed. It is a NA study. The enrollment target is 330 participants. The study started on 2013-09. Estimated completion is 2018-07.
What interventions are being tested in trial NCT02802449?
The interventions under investigation include: Placebo (DRUG), 25 Hydroxy- Vitamin D3 [25 (OH) D3] (DRUG).
Who is sponsoring clinical trial NCT02802449?
This trial is sponsored by Charles Drew University of Medicine and Science, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02802449's enrollment target sits among peer trials
330 307th of 2000 higher than 1,693 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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