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Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT03358524
Collaborator
(none)
69
Enrollment
1
Location
2
Arms
5.1
Actual Duration (Months)
13.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin E 400 UNT
  • Drug: Placebo oral capsule
 Phase 4

Detailed Description

One of obesity treatments that play important role is antioxidant diet. The effects of vitamin E supplementation as an antioxidant treatment in obese adolescent have not been concluded yet in Indonesia. The primary aim of this study is to observe oxidative stress biomarker (isoprostane) in obese teenagers who consume vitamin E for 2 months. The secondary aim is to observe their body mass index and lipid profile after supplementation

The study is randomized, double blind, placebo controlled trial in design and employed a consecutive sampling technique to sample subjects of 70 obese adolescent age 14 - 18 in senior high schools Jakarta.

Blood tests of lipid profile (total cholesterol, HDL, LDL, Triglyceride), fasting blood glucose, liver function (AST,ALT) and oxidative stress biomarker (isoprostane) were taken for every subject after done fasting for 12 hours.

This study is a randomized allocation and double blind technique. subjects divided into two groups, which one group receiving treatment of vitamin E and other group receiving placebo.

The dose and duration of vitamin E treatment is 400 IU per day for 2 months. At the end of treatment, all subjects had to run the same medical interview, physical examination and blood test.

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
Actual Study Start Date :
Sep 28, 2017
Actual Primary Completion Date :
Feb 20, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin E 400 IU

Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks

Drug: Vitamin E 400 UNT
Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)
Other Names:
  • Vitamin E

    		•
    Placebo Comparator: Placebo

    Placebo capsule once per day orally for 8 weeks

    Drug: Placebo oral capsule
    sugar capsule manufactured to mimic vitamin E capsule once per day
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Isoprostane (oxidative stress) [8 weeks]

      pg/ml

    Secondary Outcome Measures

    1. Total Cholesterol [8 weeks]

      mg/dl

    2. LDL Cholesterol [8 weeks]

      mg/dl

    3. HDL Cholesterol [8 weeks]

      mg/dl

    4. Triglycerides [8 weeks]

      mg/dl

    5. Body weight [8 weeks]

      kilograms

    6. Body Height [8 weeks]

      centimeters

    7. BMI [8 weeks]

      kg/m^2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Obesity BMI ≥ p95 (CDC growth curve)
    Exclusion Criteria:

    • Consuming antioxidants drug regularly within recruiting time

    • Consuming Orlistat

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SMA Labschool Jakarta Indonesia 13220

    Sponsors and Collaborators

    • Indonesia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ali Alhadar, Pediatric Fellowship at Pediatric Nutrition and Metabolic disease, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT03358524
    Other Study ID Numbers:
    • 001
    First Posted:
    Nov 30, 2017
    Last Update Posted:
    Mar 2, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pediatric Obesity
    Vitamins
    Vitamin E
    Tocopherols
    Tocotrienols
    alpha-Tocopherol

    Study Results

    No Results Posted as of Mar 2, 2018