The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Obesity

Treatments: Dietary Supplement: Vitamin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01405352

89-04-27-11869

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 20 to 52 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 3 patient groups, including a placebo group

Non obese/ vitamin A

Active Comparator group

Description:

Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months .

Treatment:

Dietary Supplement: Vitamin A

obese/ placebo

Placebo Comparator group

Description:

obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months .

Treatment:

Dietary Supplement: Vitamin A

Obese/ vitamin A

Active Comparator group

Description:

obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months

Treatment:

Dietary Supplement: Vitamin A