Atherosclerosis
Conditions
Keywords
Atherosclerosis, Coronary Artery Disease, Vitamin A, CD4-Positive T-Lymphocytes, gene expression
Brief summary
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).
Detailed description
Atherosclerosis, the leading cause of death and disability in the world, is considered an inflammatory disease with a complex etiology. The immune system has a prominent role in the formation, development and destabilization of atherosclerotic plaques. A whole range of identified cytokines have been shown to play a part in atherogenesis, some with proatherogenic properties while others having antiatherogenic properties. With increasing evidence for the significant role of inflammation and the cytokines involved together with the Th1/Th2 imbalance in atherosclerosis and its progression to Coronary artery diseases (CADs), the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. high level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL 12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.
Interventions
DRUGVitamin A
1 cap vitamin A 25000 IU/day for 3 month
DRUGplacebo
1 cap placebo/day for 3 month
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SGPT | Change from baseline at 4 months |
| serum Total cholesterol | Change from baseline at 4 months |
| serum HDL cholesterol | Change from baseline at 4 months |
| serum triglycerides level | Change from baseline at 4 months |
| RBP/ TTR ratio | Change from baseline at 4 months |
| PBMC's proliferation (BrdU colorimetric) | Change from baseline at 4 months |
| complete blood count (CBC) | Change from baseline at 4 months |
| SGOT | Change from baseline at 4 months |
Secondary
| Measure | Time frame |
|---|---|
| gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification) | Change from baseline at 4 months |
Countries
Iran
Outcome results
None listed