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The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Vitamin A (Dietary Supplement)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Tehran University of Medical Sciences

Summary

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.

Clinical Details

Official title: The Effect of Vitamin A Supplementation on CD4+ T-cell Secretion in Obese Individuals

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Complete Blood Count-diff

Serum HDL concentrations

Serum LDL concentrations

Serum total cholesterol concentrations

Serum Triglycerides concentrations

Serum SGOT concentrations

Serum SGPT concentrations

Serum T3 concentrations

Serum T4 concentrations

Serum TSH concentrations

Serum FBS concentrations

Serum CRP concentrations

Serum RF concentrations

Secondary outcome:

Serum IL-2 concentrations

Serum IL-6 concentrations

Serum IL-10 concentrations

Serum IL-12 concentrations

Serum IL-13 concentrations

Serum IL-17 concentrations

Seum IL-1β concentrations

Serum TGF β concentrations

serum IFN γ concentrations

serum Angiotensin П concentrations

Detailed description: 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.

Eligibility

Minimum age: 20 Years. Maximum age: 52 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Tehran University of Medical Sciences, School of Public Health, Tehran, Iran, Islamic Republic of
Additional Information

Starting date: February 2010
Last updated: July 28, 2011

Page last updated: August 20, 2015

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