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

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

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Obesity, Adolescent
• Intervention / Treatment: Drug: Vitamin E 400 UNT; Drug: Placebo oral capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 13220
    • SMA Labschool

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obesity BMI ≥ p95 (CDC growth curve)

Exclusion Criteria:

• Consuming antioxidants drug regularly within recruiting time
• Consuming Orlistat

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin E 400 IU; Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks	Drug: Vitamin E 400 UNT; Vitamin-E capsule (alpha tocopherol) 400 IU (once per day); Other Names: Vitamin E
PLACEBO_COMPARATOR: Placebo; Placebo capsule once per day orally for 8 weeks	Drug: Placebo oral capsule; sugar capsule manufactured to mimic vitamin E capsule once per day; 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

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2017
• Primary Completion (ACTUAL): February 20, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: November 25, 2017
• First Posted (ACTUAL): November 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Tocotrienols
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No