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The Study of the Effects of Vitamin A on Immune System in Patients With Atherosclerosis

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atherosclerosis

Intervention: vitamin A (Drug); placebo (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Ali Akbar saboor Yaraghi, PhD, Study Chair, Affiliation: Tehran University of Medical Sciences
Maryam Mahmoudi, MD, PhD student, Principal Investigator, Affiliation: Tehran University of Medical Siences
Fereidon Siassi, PhD, Study Chair, Affiliation: Tehran University of Medical Sciences

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 3 months on immune system and Th1/Th2 balance in patients with and without atherosclerosis (documented with angiography).

Clinical Details

Official title: The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Atherosclerosis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Serum levels of IL4, IL10, IFN γ, IL2, IL12

PBMC supernatant levels of IL4, IL10, IFN γ, IL2, IL12

Secondary outcome:

serum Total cholesterol

serum HDL cholesterol

serum triglycerides level

serum Apo A, Apo B and CRP levels

serum oxLDL

RBP/ TTR ratio

lymphocyte proliferation assay (MTT)

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.

Eligibility

Minimum age: 35 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Tehran University of Medical Sciences, School of Public Health, Tehran, Iran, Islamic Republic of
Additional Information

Starting date: September 2009
Last updated: June 2, 2012

Page last updated: August 20, 2015

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