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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03358524
Other study ID # 001
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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