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N/A N=96 Randomized Quadruple-blind Treatment

Vitamin D Repletion in Coronary Artery Disease

Vitamin D Deficiency · Coronary Artery Disease · Endothelial Dysfunction · Inflammation

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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