NCT01414972

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

August 11, 2011

Status Verified

August 1, 2011

Enrollment Period

8 months

First QC Date

February 14, 2011

Last Update Submit

August 10, 2011

Conditions

Atherosclerosis

Keywords

AtherosclerosisCoronary Artery DiseaseVitamin ACD4-Positive T-Lymphocytesgene expression

Outcome Measures

Primary Outcomes (8)

  • serum Total cholesterol

    Change from baseline at 4 months

  • serum HDL cholesterol

    Change from baseline at 4 months

  • serum triglycerides level

    Change from baseline at 4 months

  • RBP/ TTR ratio

    Change from baseline at 4 months

  • PBMC's proliferation (BrdU colorimetric)

    Change from baseline at 4 months

  • complete blood count (CBC)

    Change from baseline at 4 months

  • SGOT

    Change from baseline at 4 months

  • SGPT

    Change from baseline at 4 months

Secondary Outcomes (1)

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

    Change from baseline at 4 months

Study Arms (3)

patients 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

patients 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

people without athrosclerosis/ vitamin a

ACTIVE COMPARATOR

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

Drug: Vitamin A

Interventions

Vitamin ADRUG

1 cap vitamin A 25000 IU/day for 3 month

patients with atherosclerosis/ vitamin Apeople without athrosclerosis/ vitamin a
placeboDRUG

1 cap placebo/day for 3 month

patients with atherosclerosis/ placebo

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences, School of Public Health

Tehran, Iran

Location

MeSH Terms

Conditions

AtherosclerosisCoronary Artery Disease

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Ali Akbar saboor Yaraghi, PhD

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Azadeh Mottaghi, PhD student

    Tehran University of Medical Siences

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

February 14, 2011

First Posted

August 11, 2011

Study Start

May 1, 2010

Primary Completion

January 1, 2011

Study Completion

November 1, 2011

Last Updated

August 11, 2011

Record last verified: 2011-08

Locations

IR(1)