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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01414972
Other study ID # 89-01-27-10471
Secondary ID
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


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
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