A Phase 4 interventional study of Vitamin E 400 UNT and Placebo oral capsule in Obesity, Adolescent and Oxidative Stress, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by Indonesia University · Phase 4, Interventional, and Treatment
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
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.
1,131 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 69 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks
Drug: Vitamin E 400 UNT
Placebo capsule once per day orally for 8 weeks
Drug: Placebo oral capsule
Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)
Also known as: Vitamin E
sugar capsule manufactured to mimic vitamin E capsule once per day
Also known as: Placebo
Isoprostane (oxidative stress)
pg/ml
Time frame: 8 weeks
Total Cholesterol
mg/dl
Time frame: 8 weeks
LDL Cholesterol
mg/dl
Time frame: 8 weeks
HDL Cholesterol
mg/dl
Time frame: 8 weeks
Triglycerides
mg/dl
Time frame: 8 weeks
Body weight
kilograms
Time frame: 8 weeks
Body Height
centimeters
Time frame: 8 weeks
BMI
kg/m\^2
Time frame: 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Feb 2018, 4 months.
Of 14 phase 4 interventional studies under Pediatric Obesity, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's 4 months is below that.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin E