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The Study of the Effects of Vitamin A on Immune System in Patients With 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, Th1 Cells, Th2 Cells

Eligibility Criteria

35 Years - 60 Years (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 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

with atherosclerosis/ vitamin A

with atherosclerosis/ placebo

without atherosclerosis/ vitamin A

without athrosclerosis/ placebo

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

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

patients in whom significant (e.g. stenosis ≥ 50%) CAD is ruled out by coronary angiography, who receive placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
August 20, 2009
Last Updated
June 2, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00963222
Brief Title
The Study of the Effects of Vitamin A on Immune System in Patients With Atherosclerosis
Official Title
The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 3 months on immune system and Th1/Th2 balance in patients with and without atherosclerosis (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, Th1 Cells, Th2 Cells

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
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
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
without atherosclerosis/ vitamin A
Arm Type
Active Comparator
Arm Description
patients in whom significant (e.g. stenosis ≥ 50%) CAD is ruled out by coronary angiography, who receive 2500 Iu/day vitamin A
Arm Title
without athrosclerosis/ placebo
Arm Type
Placebo Comparator
Arm Description
patients in whom significant (e.g. stenosis ≥ 50%) CAD is ruled out by coronary angiography, who receive placebo
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 levels of IL4, IL10, IFN γ, IL2, IL12
Time Frame
first day and after 3 month
Title
PBMC supernatant levels of IL4, IL10, IFN γ, IL2, IL12
Time Frame
first day and after 3 month
Secondary Outcome Measure Information:
Title
serum Total cholesterol
Time Frame
first day and after 3 month
Title
serum HDL cholesterol
Time Frame
first day and after 3 month
Title
serum triglycerides level
Time Frame
first day and after 3 month
Title
serum Apo A, Apo B and CRP levels
Time Frame
first day and after 3 month
Title
serum oxLDL
Time Frame
first day and after 3 month
Title
RBP/ TTR ratio
Time Frame
first day and after 3 month
Title
lymphocyte proliferation assay (MTT)
Time Frame
first day and after 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 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
Maryam Mahmoudi, MD, PhD student
Organizational Affiliation
Tehran University of Medical Siences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fereidon Siassi, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
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 Study of the Effects of Vitamin A on Immune System in Patients With Atherosclerosis

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