SMA Labschool
Jakarta, 13220, Indonesia
NCT Number: NCT03358524
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
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Notify Me14 year–18 year
All sexes
Interventional
Phase 4
Jakarta, 13220, Indonesia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)
Other names: Vitamin E
sugar capsule manufactured to mimic vitamin E capsule once per day
Other names: Placebo
Time frame: 8 weeks
pg/ml
Time frame: 8 weeks
mg/dl
Time frame: 8 weeks
mg/dl
Time frame: 8 weeks
mg/dl
Time frame: 8 weeks
mg/dl
Time frame: 8 weeks
kilograms
Time frame: 8 weeks
centimeters
Time frame: 8 weeks
kg/m^2
Indonesia University
Other
Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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