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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358524
• Other study ID #: 001
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2017
• Last updated: March 1, 2018
• Start date: September 28, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 1, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• Obesity BMI = p95 (CDC growth curve)

Exclusion Criteria:

• Consuming antioxidants drug regularly within recruiting time

• Consuming Orlistat

Related Conditions & MeSH terms

• Obesity, Adolescent
• Oxidative Stress
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
Indonesia	SMA Labschool	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isoprostane (oxidative stress)	pg/ml	8 weeks
Secondary	Total Cholesterol	mg/dl	8 weeks
Secondary	LDL Cholesterol	mg/dl	8 weeks
Secondary	HDL Cholesterol	mg/dl	8 weeks
Secondary	Triglycerides	mg/dl	8 weeks
Secondary	Body weight	kilograms	8 weeks
Secondary	Body Height	centimeters	8 weeks
Secondary	BMI	kg/m^2	8 weeks