The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01405352
• Other study ID #: 89-04-27-11869
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 14, 2011
• Last updated: July 28, 2011
• Start date: February 2010
• Est. completion date: August 2013

Study information

• Verified date: July 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 84
• Est. completion date: August 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 52 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Vitamin A
25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences, School of Public Health	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Blood Count-diff		Change from baseline at 4 months	No
Primary	Serum HDL concentrations		Change from baseline at 4 months	No
Primary	Serum LDL concentrations		Change from baseline at 4 months	No
Primary	Serum total cholesterol concentrations		Change from baseline at 4 months	No
Primary	Serum Triglycerides concentrations		Change from baseline at 4 months	No
Primary	Serum SGOT concentrations		Change from baseline at 4 months	No
Primary	Serum SGPT concentrations		Change from baseline at 4 months	No
Primary	Serum T3 concentrations		Change from baseline at 4 months	No
Primary	Serum T4 concentrations		Change from baseline at 4 months	No
Primary	Serum TSH concentrations		Change from baseline at 4 months	No
Primary	Serum FBS concentrations		Change from baseline at 4 months	No
Primary	Serum CRP concentrations		Change from baseline at 4 months	No
Primary	Serum RF concentrations		Change from baseline at 4 months	No
Secondary	Serum IL-2 concentrations		Change from baseline at 4 months	No
Secondary	Serum IL-6 concentrations		Change from baseline at 4 months	No
Secondary	Serum IL-10 concentrations		Change from baseline at 4 months	No
Secondary	Serum IL-12 concentrations		Change from baseline at 4 months	No
Secondary	Serum IL-13 concentrations		Change from baseline at 4 months	No
Secondary	Serum IL-17 concentrations		Change from baseline at 4 months	No
Secondary	Seum IL-1ß concentrations		Change from baseline at 4 months	No
Secondary	Serum TGF ß concentrations		Change from baseline at 4 months	No
Secondary	serum IFN ? concentrations		Change from baseline at 4 months	No
Secondary	serum Angiotensin ? concentrations		Change from baseline at 4 months	No