Atherosclerosis Clinical Trial
Official title:
The Effect of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by T CD4+ Lymphocyte in Atherosclerotic Patients
Verified date | August 2011 |
Source | Tehran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 4 months on gene expression of T CD4+ lymphocyte in atherosclerotic patients(documented with angiography).
Status | Enrolling by invitation |
Enrollment | 45 |
Est. completion date | November 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 70 Years |
Eligibility |
Inclusion Criteria: • The criteria for enrollment of the patients and control subjects is consecutive patients of both sexes referred to the Division of Cardiology of the one of the Hospitals of Tehran University of Medical Sciences for coronary angiography for investigation of chest pain and/or suspected CAD. Exclusion Criteria: - Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR - Patients who have allergy to vitamin A compounds, OR - Patients who have used vitamin supplements in last 3 months. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Tehran University of Medical Sciences, School of Public Health | Tehran |
Lead Sponsor | Collaborator |
---|---|
Tehran University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum Total cholesterol | Change from baseline at 4 months | No | |
Primary | serum HDL cholesterol | Change from baseline at 4 months | No | |
Primary | serum triglycerides level | Change from baseline at 4 months | No | |
Primary | RBP/ TTR ratio | Change from baseline at 4 months | No | |
Primary | PBMC's proliferation (BrdU colorimetric) | Change from baseline at 4 months | No | |
Primary | complete blood count (CBC) | Change from baseline at 4 months | No | |
Primary | SGOT | Change from baseline at 4 months | No | |
Primary | SGPT | Change from baseline at 4 months | No | |
Secondary | gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification) | Change from baseline at 4 months | No |
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