Ignite Creation Date:
2024-05-06 @ 12:25 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01570309
Status:
COMPLETED
Last Update Posted:
2013-10-10
First Post:
2012-03-26
Brief Title:
Vitamin D Repletion in Coronary Artery Disease
Sponsor:
Seth I Sokol MD
Organization:
New York City Health and Hospitals Corporation
Study Overview
Official Title:
The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 citiesTo 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
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
Detailed Description:
100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50000 IU oral ergocalciferol active treatment group or placebo delayed intervention group once a week for 12 weeks The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules s-VCAM s-ICAM soluble e-selectin Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway IL-12 IFN-g and CXCL-10 - IFN-g axis the investigators have linked to coronary atherogenesis independent of CRP and poor CV outcomes will be measured over the 12 week study period Given published evidence showing that Vit D can influence this T- cell pathway specific aim 2 will add mechanistic insights to this proposal High sensitivity C-reactive protein hs-CRP will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None