Coronary Artery Disease, Cardiovascular Disease
Conditions
Keywords
CAD, Vitamin D, CVD
Brief summary
The purpose of this study is to evaluate the effect of Vitamin D supplementation on cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role in plaque formation in arteries. This study will determine the levels of Vitamin D and T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation will affect future events such as heart attach and stroke.
Interventions
DIETARY_SUPPLEMENTVitamin D
Vitamin D 3000 IU daily
OTHERNo medication
No intervention
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* between the ages of 30 and 80 years * have a history of medically treated coronary artery disease
Exclusion criteria
* history of smoking in the past 2 years * history of diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| increase in T-regulatory Cells | 1 year | We expect significant improvement in the suppressive capacity, with or without increase in the number, of circulating T-regs after vitamin D supplementation. This increase in T-regs function will correlate with improvement in clinical parameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10 | 1 year | We also expect that vitamin D supplementation will decrease the levels of pro-inflammatory cytokines and sTNFR1 and increase the level of serum IL-10 |
Countries
United States
Outcome results
None listed