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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin E 400 IU | Experimental | Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks |
|
| Placebo | Placebo Comparator | Placebo capsule once per day orally for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E 400 UNT | Drug | Vitamin-E capsule (alpha tocopherol) 400 IU (once per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Isoprostane (oxidative stress) | pg/ml | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | mg/dl | 8 weeks |
| LDL Cholesterol | mg/dl | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMA Labschool | Jakarta | 13220 | Indonesia |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo oral capsule | Drug | sugar capsule manufactured to mimic vitamin E capsule once per day |
|
|
| HDL Cholesterol |
mg/dl |
| 8 weeks |
| Triglycerides | mg/dl | 8 weeks |
| Body weight | kilograms | 8 weeks |
| Body Height | centimeters | 8 weeks |
| BMI | kg/m^2 | 8 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |