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

NCT ID: NCT03358524

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-28
• Study Completion Date: 2018-03-01

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.

Conditions

Obesity, Adolescent; Oxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin E 400 IU

Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks

Group Type: EXPERIMENTAL

Vitamin E 400 UNT

Intervention Type: DRUG

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

Placebo

Placebo capsule once per day orally for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

sugar capsule manufactured to mimic vitamin E capsule once per day

Interventions

Vitamin E 400 UNT

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

Intervention Type: DRUG

Placebo oral capsule

sugar capsule manufactured to mimic vitamin E capsule once per day

Intervention Type: DRUG

Other Intervention Names

Vitamin E; Placebo

Eligibility Criteria

Inclusion Criteria

• Obesity BMI ≥ p95 (CDC growth curve)

Exclusion Criteria

• Consuming antioxidants drug regularly within recruiting time
• Consuming Orlistat

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Ali Alhadar

Pediatric Fellowship at Pediatric Nutrition and Metabolic disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SMA Labschool

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id