N/A
N=96
Vitamin D Repletion in Coronary Artery Disease
Vitamin D Deficiency · Coronary Artery Disease · Endothelial Dysfunction · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT01570309 ↗Enrolled (actual)
96
Serious AEs
21.1%
Results posted
Oct 2013
Primary outcome: Primary: Endothelial Function — 0.13; -0.04 reactive hypermia index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ergocalciferol (Drug); Sugar pill (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seth I. Sokol, M.D.
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Function |
0.13; -0.04 | — |
| PRIMARY Inflammation - |
-0.17; -0.05 | — |
| PRIMARY Inflammation |
-10.96; -2.33 | — |
| PRIMARY Inflammation |
-10.96; -2.33 | — |
| PRIMARY Inflammation |
-10.96; -2.33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male and nonpregnant females greater than 18 years of age
- ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
- Serum 25-hydroxyvitamin D 800 IU/day of vitamin D
- Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
Data sourced from ClinicalTrials.gov (NCT01570309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.