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NCT01570309 · ClinicalTrials.gov registry record · NA
Vitamin D Repletion in Coronary Artery Disease
A NA study of Coronary Artery Disease and Inflammation, sponsored by Seth I. Sokol, M.D..
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
- 2
- Study locations
NCT01570309: Completed NA study of Coronary Artery Disease and Inflammation, sponsored by Seth I. Sokol, M.D..
NCT01570309 is a NA study of Coronary Artery Disease and Inflammation that has completed, run by Seth I. Sokol, M.D.. The registered enrollment target is 96 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01570309, a NA study of Coronary Artery Disease and Inflammation, has completed, sponsored by Seth I. Sokol, M.D..
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
- 2
- Study locations
Study Summary
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed. The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.
Primary Outcome
Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.
Conditions Studied
Interventions
- DRUG Ergocalciferol
- OTHER Sugar pill
Study Locations (2)
New York
- Jacobi Medical Center - The Bronx
- Montefiore Medical Center / Weiler division - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-03 |
| Phase | NA |
What the finished NCT01570309 record still lists
NCT01570309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Ergocalciferol is the first listed.
NCT01570309 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01570309 about?
NCT01570309 is a clinical study titled "Vitamin D Repletion in Coronary Artery Disease". Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United S...
What is the current status of trial NCT01570309?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2008-08. Estimated completion is 2011-03.
What conditions does trial NCT01570309 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Inflammation, Vitamin D Deficiency, Endothelial Dysfunction.
What interventions are being tested in trial NCT01570309?
The interventions under investigation include: Ergocalciferol (DRUG), Sugar pill (OTHER).
Who is sponsoring clinical trial NCT01570309?
This trial is sponsored by Seth I. Sokol, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01570309 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01570309's enrollment target sits among peer trials
96 151st of 219 higher than 69 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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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