The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity
- Conditions
- Obesity
- Interventions
- Dietary Supplement: Vitamin A
- Registration Number
- NCT01405352
- Lead Sponsor
- Tehran University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non obese/ vitamin A Vitamin A Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months . obese/ placebo Vitamin A obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months . Obese/ vitamin A Vitamin A obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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
Trial Locations
- Locations (1)
Tehran University of Medical Sciences, School of Public Health
🇮🇷Tehran, Iran, Islamic Republic of