Clinical Trials Directory

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UnknownNCT01414972

The Effect of Vitamin A on Atherosclerosis

The Effect of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by T CD4+ Lymphocyte in Atherosclerotic Patients

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Tehran University of Medical Sciences · Academic / Other
Sex
All
Age
35 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGVitamin A1 cap vitamin A 25000 IU/day for 3 month
DRUGplacebo1 cap placebo/day for 3 month

Timeline

Start date
2010-05-01
Primary completion
2011-01-01
Completion
2011-11-01
First posted
2011-08-11
Last updated
2011-08-11

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT01414972. Inclusion in this directory is not an endorsement.