The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01405352
First received: February 14, 2011
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Obesity
Dietary Supplement: Vitamin A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin A Supplementation on CD4+ T-cell Secretion in Obese Individuals

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Complete Blood Count-diff [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum HDL concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum LDL concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum total cholesterol concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum Triglycerides concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum SGOT concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum SGPT concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum T3 concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum T4 concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum TSH concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum FBS concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum CRP concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum RF concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum IL-2 concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum IL-6 concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum IL-10 concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum IL-12 concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum IL-13 concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum IL-17 concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Seum IL-1β concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • Serum TGF β concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • serum IFN γ concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]
  • serum Angiotensin П concentrations [ Time Frame: Change from baseline at 4 months ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: February 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   20 Years to 52 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405352

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences, School of Public Health
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Ali Akbar Saboor Yaraghi/Assistant professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01405352     History of Changes
Other Study ID Numbers: 89-04-27-11869
Study First Received: February 14, 2011
Last Updated: July 28, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
obesity
vitamin A
immune system

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014