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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01570309
The ClinicalTrials.gov registry entry for NCT01570309 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (93% lower). The listed sponsor is Seth I. Sokol, M.D., which has 1 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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