The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Vitamin A

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran University of Medical Sciences, School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non obese/ 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 .	Dietary supplement: Vitamin A; 25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month
Placebo Comparator: obese/ placebo; 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; 25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month
Active Comparator: Obese/ 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): July 29, 2011

Study Record Updates

• Last Update Posted (Estimate): July 29, 2011
• Last Update Submitted That Met QC Criteria: July 28, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: obesity; immune system; vitamin A
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 89-04-27-11869