The Study of the Effects of Vitamin A on Immune System in Patients With Atherosclerosis

NCT00963222 | Unknown Phase 4 DMC

• 1 other identifier: 86-04-27-6617
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Atherosclerosis

Keywords

Atherosclerosis; Coronary Artery Disease; Vitamin A; CD4-Positive T-Lymphocytes; Th1 Cells; Th2 Cells

Outcome Measures

Primary Outcomes (2)

• Serum levels of IL4, IL10, IFN γ, IL2, IL12

  first day and after 3 month

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

  first day and after 3 month

Secondary Outcomes (7)

• serum Total cholesterol

  first day and after 3 month

• serum HDL cholesterol

  first day and after 3 month

• serum triglycerides level

  first day and after 3 month

• serum Apo A, Apo B and CRP levels

  first day and after 3 month

• serum oxLDL

  first day and after 3 month

Study Arms (4)

with atherosclerosis/ vitamin A

ACTIVE COMPARATOR

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

Drug: vitamin A

with atherosclerosis/ placebo

PLACEBO COMPARATOR

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

Drug: placebo

without atherosclerosis/ vitamin A

ACTIVE COMPARATOR

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

Drug: vitamin A

without athrosclerosis/ placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

vitamin A DRUG

1 cap vitamin A 25000 IU/day for 3 month

with atherosclerosis/ vitamin A; without atherosclerosis/ vitamin A

placebo DRUG

1 cap placebo/day for 3 month

with atherosclerosis/ placebo; without athrosclerosis/ placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences, School of Public Health

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Ali Akbar saboor Yaraghi, PhD

  Tehran University of Medical Sciences

  STUDY CHAIR

• Maryam Mahmoudi, MD, PhD student

  Tehran University of Medical Siences

  PRINCIPAL INVESTIGATOR

• Fereidon Siassi, PhD

  Tehran University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2013
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

IR (1)