Clinical trial NCT01405352: The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity
Official title: The Effect of Vitamin A Supplementation on CD4+ T-cell Secretion in Obese Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Keywords: obesity
vitamin A
immune system
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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 \<BMI\<29.9 kg/m2)

Primary outcomes:
measure: Complete Blood Count-diff
timeFrame: Change from baseline at 4 months
measure: Serum HDL concentrations
timeFrame: Change from baseline at 4 months
measure: Serum LDL concentrations
timeFrame: Change from baseline at 4 months
measure: Serum total cholesterol concentrations
timeFrame: Change from baseline at 4 months
measure: Serum Triglycerides concentrations
timeFrame: Change from baseline at 4 months
measure: Serum SGOT concentrations
timeFrame: Change from baseline at 4 months
measure: Serum SGPT concentrations
timeFrame: Change from baseline at 4 months
measure: Serum T3 concentrations
timeFrame: Change from baseline at 4 months
measure: Serum T4 concentrations
timeFrame: Change from baseline at 4 months
measure: Serum TSH concentrations
timeFrame: Change from baseline at 4 months
measure: Serum FBS concentrations
timeFrame: Change from baseline at 4 months
measure: Serum CRP concentrations
timeFrame: Change from baseline at 4 months
measure: Serum RF concentrations
timeFrame: Change from baseline at 4 months
Secondary outcomes:
measure: Serum IL-2 concentrations
timeFrame: Change from baseline at 4 months
measure: Serum IL-6 concentrations
timeFrame: Change from baseline at 4 months
measure: Serum IL-10 concentrations
timeFrame: Change from baseline at 4 months
measure: Serum IL-12 concentrations
timeFrame: Change from baseline at 4 months
measure: Serum IL-13 concentrations
timeFrame: Change from baseline at 4 months
measure: Serum IL-17 concentrations
timeFrame: Change from baseline at 4 months
measure: Seum IL-1β concentrations
timeFrame: Change from baseline at 4 months
measure: Serum TGF β concentrations
timeFrame: Change from baseline at 4 months
measure: serum IFN γ concentrations
timeFrame: Change from baseline at 4 months
measure: serum Angiotensin П concentrations
timeFrame: Change from baseline at 4 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences, School of Public Health
Study officials:
References: