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The Effect of Vitamin A on Atherosclerosis

Primary Purpose

Atherosclerosis

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin A
placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring Atherosclerosis, Coronary Artery Disease, Vitamin A, CD4-Positive T-Lymphocytes, gene expression

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tehran University of Medical Sciences, School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

patients with atherosclerosis/ vitamin A

patients with atherosclerosis/ placebo

people without athrosclerosis/ vitamin a

Arm Description

patients with angiographically confirmed CAD (defined as luminal stenosis ≥50% in at least one major coronary artery branch)who receive 25000 IU/day vitamin A

patients with angiographically confirmed CAD (defined as luminal stenosis ≥50% in at least one major coronary artery branch)who receive placebo

people in whom significant (e.g. stenosis ≥ 50%) CAD is ruled out by coronary angiography, who receive 2500 Iu/day vitamin A

Outcomes

Primary Outcome Measures

serum Total cholesterol
serum HDL cholesterol
serum triglycerides level
RBP/ TTR ratio
PBMC's proliferation (BrdU colorimetric)
complete blood count (CBC)
SGOT
SGPT

Secondary Outcome Measures

gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)

Full Information

First Posted
February 14, 2011
Last Updated
August 10, 2011
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01414972
Brief Title
The Effect of Vitamin A on Atherosclerosis
Official Title
The Effect of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by T CD4+ Lymphocyte in Atherosclerotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Atherosclerosis, Coronary Artery Disease, Vitamin A, CD4-Positive T-Lymphocytes, gene expression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with atherosclerosis/ vitamin A
Arm Type
Active Comparator
Arm Description
patients with angiographically confirmed CAD (defined as luminal stenosis ≥50% in at least one major coronary artery branch)who receive 25000 IU/day vitamin A
Arm Title
patients with atherosclerosis/ placebo
Arm Type
Placebo Comparator
Arm Description
patients with angiographically confirmed CAD (defined as luminal stenosis ≥50% in at least one major coronary artery branch)who receive placebo
Arm Title
people without athrosclerosis/ vitamin a
Arm Type
Active Comparator
Arm Description
people in whom significant (e.g. stenosis ≥ 50%) CAD is ruled out by coronary angiography, who receive 2500 Iu/day vitamin A
Intervention Type
Drug
Intervention Name(s)
Vitamin A
Intervention Description
1 cap vitamin A 25000 IU/day for 3 month
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 cap placebo/day for 3 month
Primary Outcome Measure Information:
Title
serum Total cholesterol
Time Frame
Change from baseline at 4 months
Title
serum HDL cholesterol
Time Frame
Change from baseline at 4 months
Title
serum triglycerides level
Time Frame
Change from baseline at 4 months
Title
RBP/ TTR ratio
Time Frame
Change from baseline at 4 months
Title
PBMC's proliferation (BrdU colorimetric)
Time Frame
Change from baseline at 4 months
Title
complete blood count (CBC)
Time Frame
Change from baseline at 4 months
Title
SGOT
Time Frame
Change from baseline at 4 months
Title
SGPT
Time Frame
Change from baseline at 4 months
Secondary Outcome Measure Information:
Title
gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)
Time Frame
Change from baseline at 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Akbar saboor Yaraghi, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Azadeh Mottaghi, PhD student
Organizational Affiliation
Tehran University of Medical Siences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of Medical Sciences, School of Public Health
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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The Effect of Vitamin A on Atherosclerosis

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