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, IL12PBMC supernatant levels of IL4, IL10, IFN γ, IL2, IL12
Secondary outcome: serum Total cholesterolserum 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
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