The Effect of Vitamin A on Atherosclerosis

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01414972
• Other study ID #: 89-01-27-10471
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 14, 2011
• Last updated: August 10, 2011
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: August 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: November 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Vitamin A
1 cap vitamin A 25000 IU/day for 3 month
• placebo
1 cap placebo/day for 3 month

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences, School of Public Health	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum Total cholesterol		Change from baseline at 4 months	No
Primary	serum HDL cholesterol		Change from baseline at 4 months	No
Primary	serum triglycerides level		Change from baseline at 4 months	No
Primary	RBP/ TTR ratio		Change from baseline at 4 months	No
Primary	PBMC's proliferation (BrdU colorimetric)		Change from baseline at 4 months	No
Primary	complete blood count (CBC)		Change from baseline at 4 months	No
Primary	SGOT		Change from baseline at 4 months	No
Primary	SGPT		Change from baseline at 4 months	No
Secondary	gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)		Change from baseline at 4 months	No