NCT01405352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Feb 2010

Typical duration for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

Enrollment Period

3 years

First QC Date

February 14, 2011

Last Update Submit

July 28, 2011

Conditions

Obesity

Keywords

obesityvitamin Aimmune system

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (3)

Non obese/ vitamin A

ACTIVE COMPARATOR

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

obese/ placebo

PLACEBO COMPARATOR

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

Obese/ vitamin A

ACTIVE COMPARATOR

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

Interventions

Vitamin ADIETARY_SUPPLEMENT

25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month

Non obese/ vitamin AObese/ vitamin Aobese/ placebo

Eligibility Criteria

Age20 Years - 52 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences, School of Public Health

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Obesity

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2011

First Posted

July 29, 2011

Study Start

February 1, 2010

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

July 29, 2011

Record last verified: 2011-07

Locations

IR(1)