The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity
Primary Purpose
Obesity
Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin A
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, vitamin A, immune system
Eligibility Criteria
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)
Sites / Locations
- Tehran University of Medical Sciences, School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Non obese/ vitamin A
obese/ placebo
Obese/ vitamin A
Arm Description
Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months .
obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months .
obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months
Outcomes
Primary Outcome Measures
Complete Blood Count-diff
Serum HDL concentrations
Serum LDL concentrations
Serum total cholesterol concentrations
Serum Triglycerides concentrations
Serum SGOT concentrations
Serum SGPT concentrations
Serum T3 concentrations
Serum T4 concentrations
Serum TSH concentrations
Serum FBS concentrations
Serum CRP concentrations
Serum RF concentrations
Secondary Outcome Measures
Serum IL-2 concentrations
Serum IL-6 concentrations
Serum IL-10 concentrations
Serum IL-12 concentrations
Serum IL-13 concentrations
Serum IL-17 concentrations
Seum IL-1β concentrations
Serum TGF β concentrations
serum IFN γ concentrations
serum Angiotensin П concentrations
Full Information
NCT ID
NCT01405352
First Posted
February 14, 2011
Last Updated
July 28, 2011
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01405352
Brief Title
The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity
Official Title
The Effect of Vitamin A Supplementation on CD4+ T-cell Secretion in Obese Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, vitamin A, immune system
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non obese/ vitamin A
Arm Type
Active Comparator
Arm Description
Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months .
Arm Title
obese/ placebo
Arm Type
Placebo Comparator
Arm Description
obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months .
Arm Title
Obese/ vitamin A
Arm Type
Active Comparator
Arm Description
obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A
Intervention Description
25000 IU/day vitamin A 4 months
1 Cap/Day
1 cap placebo/day for 4 month
Primary Outcome Measure Information:
Title
Complete Blood Count-diff
Time Frame
Change from baseline at 4 months
Title
Serum HDL concentrations
Time Frame
Change from baseline at 4 months
Title
Serum LDL concentrations
Time Frame
Change from baseline at 4 months
Title
Serum total cholesterol concentrations
Time Frame
Change from baseline at 4 months
Title
Serum Triglycerides concentrations
Time Frame
Change from baseline at 4 months
Title
Serum SGOT concentrations
Time Frame
Change from baseline at 4 months
Title
Serum SGPT concentrations
Time Frame
Change from baseline at 4 months
Title
Serum T3 concentrations
Time Frame
Change from baseline at 4 months
Title
Serum T4 concentrations
Time Frame
Change from baseline at 4 months
Title
Serum TSH concentrations
Time Frame
Change from baseline at 4 months
Title
Serum FBS concentrations
Time Frame
Change from baseline at 4 months
Title
Serum CRP concentrations
Time Frame
Change from baseline at 4 months
Title
Serum RF concentrations
Time Frame
Change from baseline at 4 months
Secondary Outcome Measure Information:
Title
Serum IL-2 concentrations
Time Frame
Change from baseline at 4 months
Title
Serum IL-6 concentrations
Time Frame
Change from baseline at 4 months
Title
Serum IL-10 concentrations
Time Frame
Change from baseline at 4 months
Title
Serum IL-12 concentrations
Time Frame
Change from baseline at 4 months
Title
Serum IL-13 concentrations
Time Frame
Change from baseline at 4 months
Title
Serum IL-17 concentrations
Time Frame
Change from baseline at 4 months
Title
Seum IL-1β concentrations
Time Frame
Change from baseline at 4 months
Title
Serum TGF β concentrations
Time Frame
Change from baseline at 4 months
Title
serum IFN γ concentrations
Time Frame
Change from baseline at 4 months
Title
serum Angiotensin П concentrations
Time Frame
Change from baseline at 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Tehran University of Medical Sciences, School of Public Health
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity
We'll reach out to this number within 24 hrs