NCT03358524

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Obesity, Adolescent
• Oxidative Stress

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-28
• Primary completion: 2018-02-20
• Completion: 2018-03-01
• First posted: 2017-11-30
• Last updated: 2018-03-02

Locations

1 site across 1 country: Indonesia