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Completed

NCT Number: NCT03358524

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

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

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SMA Labschool

Jakarta, 13220, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obesity BMI ≥ p95 (CDC growth curve)

Exclusion criteria

  • Consuming antioxidants drug regularly within recruiting time
  • Consuming Orlistat

Treatment and study plan

Vitamin E 400 UNT

Drug

Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)

Other names: Vitamin E

Placebo oral capsule

Drug

sugar capsule manufactured to mimic vitamin E capsule once per day

Other names: Placebo

Primary outcomes

  1. Isoprostane (oxidative stress)

    Time frame: 8 weeks

    pg/ml

Secondary outcomes

  1. Total Cholesterol

    Time frame: 8 weeks

    mg/dl

  2. LDL Cholesterol

    Time frame: 8 weeks

    mg/dl

  3. HDL Cholesterol

    Time frame: 8 weeks

    mg/dl

  4. Triglycerides

    Time frame: 8 weeks

    mg/dl

  5. Body weight

    Time frame: 8 weeks

    kilograms

  6. Body Height

    Time frame: 8 weeks

    centimeters

  7. BMI

    Time frame: 8 weeks

    kg/m^2

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2017
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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