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

Overview

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

Full Title of Study: “Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 20, 2018

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.

Interventions

  • Drug: Vitamin E 400 UNT
    • Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)
  • Drug: Placebo oral capsule
    • sugar capsule manufactured to mimic vitamin E capsule once per day

Arms, Groups and Cohorts

  • Experimental: Vitamin E 400 IU
    • Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks
  • Placebo Comparator: Placebo
    • Placebo capsule once per day orally for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Isoprostane (oxidative stress)
    • Time Frame: 8 weeks
    • pg/ml

Secondary Measures

  • Total Cholesterol
    • Time Frame: 8 weeks
    • mg/dl
  • LDL Cholesterol
    • Time Frame: 8 weeks
    • mg/dl
  • HDL Cholesterol
    • Time Frame: 8 weeks
    • mg/dl
  • Triglycerides
    • Time Frame: 8 weeks
    • mg/dl
  • Body weight
    • Time Frame: 8 weeks
    • kilograms
  • Body Height
    • Time Frame: 8 weeks
    • centimeters
  • BMI
    • Time Frame: 8 weeks
    • kg/m^2

Participating in This Clinical Trial

Inclusion Criteria

  • Obesity BMI ≥ p95 (CDC growth curve)

Exclusion Criteria

  • Consuming antioxidants drug regularly within recruiting time
  • Consuming Orlistat

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Alhadar, Pediatric Fellowship at Pediatric Nutrition and Metabolic disease – Indonesia University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.