The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

Study Overview
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Vitamin A


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non obese/ vitamin A<br>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<br>* 25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month<br>|
| Placebo Comparator: obese/ placebo<br>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<br>* 25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month<br>|
| Active Comparator: Obese/ vitamin A<br>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<br>* 25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Blood Count-diff |  | Change from baseline at 4 months | 
| Serum HDL concentrations |  | Change from baseline at 4 months | 
| Serum LDL concentrations |  | Change from baseline at 4 months | 
| Serum total cholesterol concentrations |  | Change from baseline at 4 months | 
| Serum Triglycerides concentrations |  | Change from baseline at 4 months | 
| Serum SGOT concentrations |  | Change from baseline at 4 months | 
| Serum SGPT concentrations |  | Change from baseline at 4 months | 
| Serum T3 concentrations |  | Change from baseline at 4 months | 
| Serum T4 concentrations |  | Change from baseline at 4 months | 
| Serum TSH concentrations |  | Change from baseline at 4 months | 
| Serum FBS concentrations |  | Change from baseline at 4 months | 
| Serum CRP concentrations |  | Change from baseline at 4 months | 
| Serum RF concentrations |  | Change from baseline at 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IL-2 concentrations |  | Change from baseline at 4 months | 
| Serum IL-6 concentrations |  | Change from baseline at 4 months | 
| Serum IL-10 concentrations |  | Change from baseline at 4 months | 
| Serum IL-12 concentrations |  | Change from baseline at 4 months | 
| Serum IL-13 concentrations |  | Change from baseline at 4 months | 
| Serum IL-17 concentrations |  | Change from baseline at 4 months | 
| Seum IL-1β concentrations |  | Change from baseline at 4 months | 
| Serum TGF β concentrations |  | Change from baseline at 4 months | 
| serum IFN γ concentrations |  | Change from baseline at 4 months | 
| serum Angiotensin П concentrations |  | Change from baseline at 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, vitamin A, immune system