A Phase 4 interventional study of Vitamin A in Obesity, sponsored by Tehran University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 20 Years to 52 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-29.
Sponsored by Tehran University of Medical Sciences · Phase 4, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 84 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months .
Dietary Supplement: Vitamin A
obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months .
Dietary Supplement: Vitamin A
obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months
Dietary Supplement: Vitamin A
25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month
Complete Blood Count-diff
Time frame: Change from baseline at 4 months
Serum HDL concentrations
Time frame: Change from baseline at 4 months
Serum LDL concentrations
Time frame: Change from baseline at 4 months
Serum total cholesterol concentrations
Time frame: Change from baseline at 4 months
Serum Triglycerides concentrations
Time frame: Change from baseline at 4 months
Serum SGOT concentrations
Time frame: Change from baseline at 4 months
Serum SGPT concentrations
Time frame: Change from baseline at 4 months
Serum T3 concentrations
Time frame: Change from baseline at 4 months
Serum T4 concentrations
Time frame: Change from baseline at 4 months
Serum TSH concentrations
Time frame: Change from baseline at 4 months
Serum FBS concentrations
Time frame: Change from baseline at 4 months
Serum CRP concentrations
Time frame: Change from baseline at 4 months
Serum RF concentrations
Time frame: Change from baseline at 4 months
Serum IL-2 concentrations
Time frame: Change from baseline at 4 months
Serum IL-6 concentrations
Time frame: Change from baseline at 4 months
Serum IL-10 concentrations
Time frame: Change from baseline at 4 months
Serum IL-12 concentrations
Time frame: Change from baseline at 4 months
Serum IL-13 concentrations
Time frame: Change from baseline at 4 months
Serum IL-17 concentrations
Time frame: Change from baseline at 4 months
Seum IL-1β concentrations
Time frame: Change from baseline at 4 months
Serum TGF β concentrations
Time frame: Change from baseline at 4 months
serum IFN γ concentrations
Time frame: Change from baseline at 4 months
serum Angiotensin П concentrations
Time frame: Change from baseline at 4 months
This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences