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The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 3 months on immune system and Th1/Th2 balance in patients with and without atherosclerosis (documented with angiography).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with atherosclerosis/ vitamin A | Active Comparator | patients with angiographically confirmed CAD (defined as luminal stenosis ≥50% in at least one major coronary artery branch)who receive 25000 IU/day vitamin A |
|
| with atherosclerosis/ placebo | Placebo Comparator | patients with angiographically confirmed CAD (defined as luminal stenosis ≥50% in at least one major coronary artery branch)who receive placebo |
|
| without atherosclerosis/ vitamin A | Active Comparator | patients in whom significant (e.g. stenosis ≥ 50%) CAD is ruled out by coronary angiography, who receive 2500 Iu/day vitamin A |
|
| without athrosclerosis/ placebo | Placebo Comparator | patients in whom significant (e.g. stenosis ≥ 50%) CAD is ruled out by coronary angiography, who receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin A | Drug | 1 cap vitamin A 25000 IU/day for 3 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of IL4, IL10, IFN γ, IL2, IL12 | first day and after 3 month | |
| PBMC supernatant levels of IL4, IL10, IFN γ, IL2, IL12 | first day and after 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| serum Total cholesterol | first day and after 3 month | |
| serum HDL cholesterol | first day and after 3 month | |
| serum triglycerides level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Akbar saboor Yaraghi, PhD | Tehran University of Medical Sciences | Study Chair |
| Maryam Mahmoudi, MD, PhD student | Tehran University of Medical Siences | Principal Investigator |
| Fereidon Siassi, PhD | Tehran University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran University of Medical Sciences, School of Public Health | Tehran | Tehran Province | Iran |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| placebo | Drug | 1 cap placebo/day for 3 month |
|
| first day and after 3 month |
| serum Apo A, Apo B and CRP levels | first day and after 3 month |
| serum oxLDL | first day and after 3 month |
| RBP/ TTR ratio | first day and after 3 month |
| lymphocyte proliferation assay (MTT) | first day and after 3 month |
| D003327 |
| Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |