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

Primary Purpose

Obesity, Adolescent, Oxidative Stress

Status

Completed

Phase

Phase 4

Locations

Indonesia

Study Type

Interventional

Intervention

Vitamin E 400 UNT

Placebo oral capsule

About this trial

This is an interventional treatment trial for Obesity, Adolescent

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Obesity BMI ≥ p95 (CDC growth curve)

Exclusion Criteria:

Consuming antioxidants drug regularly within recruiting time
Consuming Orlistat

Sites / Locations

SMA Labschool

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin E 400 IU

Placebo

Arm Description

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

Placebo capsule once per day orally for 8 weeks

Outcomes

Primary Outcome Measures

Isoprostane (oxidative stress)

pg/ml

Secondary Outcome Measures

Total Cholesterol

mg/dl

LDL Cholesterol

mg/dl

HDL Cholesterol

mg/dl

Triglycerides

mg/dl

Body weight

kilograms

Body Height

centimeters

BMI

kg/m^2

Full Information

NCT ID

NCT03358524

First Posted

November 25, 2017

Last Updated

March 1, 2018

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT03358524

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

September 28, 2017 (Actual)

Primary Completion Date

February 20, 2018 (Actual)

Study Completion Date

March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Adolescent, Oxidative Stress

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin E 400 IU

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsule once per day orally for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Vitamin E 400 UNT

Other Intervention Name(s)

Vitamin E

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Other Intervention Name(s)

Placebo

Intervention Description

sugar capsule manufactured to mimic vitamin E capsule once per day

Primary Outcome Measure Information:

Title

Isoprostane (oxidative stress)

Description

pg/ml

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Total Cholesterol

Description

mg/dl

Time Frame

8 weeks

Title

LDL Cholesterol

Description

mg/dl

Time Frame

8 weeks

Title

HDL Cholesterol

Description

mg/dl

Time Frame

8 weeks

Title

Triglycerides

Description

mg/dl

Time Frame

8 weeks

Title

Body weight

Description

kilograms

Time Frame

8 weeks

Title

Body Height

Description

centimeters

Time Frame

8 weeks

Title

BMI

Description

kg/m^2

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

SMA Labschool

City

Jakarta

ZIP/Postal Code

13220

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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