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

Study Overview
=================
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

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.

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

Conditions
-----------------
Obesity, Adolescent, Oxidative Stress

Intervention / Treatment
-----------------
* Drug: Vitamin E 400 UNT
* Drug: Placebo oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obesity BMI ≥ p95 (CDC growth curve) Exclusion Criteria: Consuming antioxidants drug regularly within recruiting time Consuming Orlistat

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E 400 IU<br>Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks | Drug: Vitamin E 400 UNT<br>* Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)<br>* Other names: Vitamin E;|
| Placebo Comparator: Placebo<br>Placebo capsule once per day orally for 8 weeks | Drug: Placebo oral capsule<br>* sugar capsule manufactured to mimic vitamin E capsule once per day<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isoprostane (oxidative stress) | pg/ml | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol | mg/dl | 8 weeks | 
| LDL Cholesterol | mg/dl | 8 weeks | 
| HDL Cholesterol | mg/dl | 8 weeks | 
| Triglycerides | mg/dl | 8 weeks | 
| Body weight | kilograms | 8 weeks | 
| Body Height | centimeters | 8 weeks | 
| BMI | kg/m^2 | 8 weeks |