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The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

NCT ID: NCT01405352

Last Updated: 2011-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-08-31

Brief Summary

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In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4 month supplementation of vitamin A will be compared with placebo intaking group.

Detailed Description

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Obesity is a chronic disease consisting of the increase in body fat stores. Obesity is an important health concern because of its well known relationships with metabolic and endocrine disorders such as cardiovascular disease, type 2 diabetes, hypertension and immune dysfunction. Low-grade systemic inflammation, confirmed by the increase of inflammatory markers such as C-reactive protein and interleukin-6 has been observed in obesity. CD4+ T-helpers are the most important regulators of immune system. Epidemiological evidence has linked obesity to several (but not all) autoimmune disorders, including inflammatory bowel disease (IBD) and psoriasis .Some sublineages of T- helpers plays core roles in immune dysfunction, and recent evidence demonstrates that an imbalance of T-cell subgroups including Th1, Th2, Th17 and Treg has occurred in obesity. This imbalance is the redirection of the immune response from most often Th2 and Treg like responses to Th1 and Th17 like responses respectively, however the opposite is desired. 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 and TNF α 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.

Conditions

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Obesity

Keywords

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obesity vitamin A immune system

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Non obese/ vitamin A

Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months .

Group Type ACTIVE_COMPARATOR

Vitamin A

Intervention Type DIETARY_SUPPLEMENT

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month

obese/ placebo

obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months .

Group Type PLACEBO_COMPARATOR

Vitamin A

Intervention Type DIETARY_SUPPLEMENT

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month

Obese/ vitamin A

obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months

Group Type ACTIVE_COMPARATOR

Vitamin A

Intervention Type DIETARY_SUPPLEMENT

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month

Interventions

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Vitamin A

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

waist to hip ratio \>0.8 and BMI\>30 kg/m2 for obese individuals waist to hip ratio \<0.8 and BMI 18.5 - 24.9 kg/m2 for Non obese individuals

Exclusion Criteria

* subjects who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
* subjects with pregnancy, lactation, menopause, diabetes
* subjects who have allergy to vitamin A compounds, OR
* subjects who have used vitamin supplements or in last 3 months, OR
* subjects with morbid obesity(BMI \>40 kg/m2),OR
* overweight subjects (25 \<BMI\<29.9 kg/m2)
Minimum Eligible Age

20 Years

Maximum Eligible Age

52 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Locations

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Tehran University of Medical Sciences, School of Public Health

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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89-04-27-11869

Identifier Type: -

Identifier Source: org_study_id