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-diffSerum 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 concentrationsSerum 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
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