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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03358524
Enrollment
69
Registered
2017-11-30
Start date
2017-09-28
Completion date
2018-03-01
Last updated
2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Adolescent, Oxidative Stress

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.

Interventions

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

DRUGPlacebo oral capsule

sugar capsule manufactured to mimic vitamin E capsule once per day

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Obesity BMI ≥ p95 (CDC growth curve)

Exclusion criteria

* Consuming antioxidants drug regularly within recruiting time * Consuming Orlistat

Design outcomes

Primary

MeasureTime frameDescription
Isoprostane (oxidative stress)8 weekspg/ml

Secondary

MeasureTime frameDescription
Body Height8 weekscentimeters
BMI8 weekskg/m\^2
HDL Cholesterol8 weeksmg/dl
Body weight8 weekskilograms
Total Cholesterol8 weeksmg/dl
LDL Cholesterol8 weeksmg/dl
Triglycerides8 weeksmg/dl

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026