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Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03358524
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : March 2, 2018
Information provided by (Responsible Party):
Ali Alhadar, Indonesia University

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

Condition or disease Intervention/treatment Phase
Obesity, Adolescent Oxidative Stress Drug: Vitamin E 400 UNT Drug: Placebo oral capsule Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : March 1, 2018

Arm Intervention/treatment
Experimental: Vitamin E 400 IU
Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks
Drug: Vitamin E 400 UNT
Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)
Other Name: Vitamin E

Placebo Comparator: Placebo
Placebo capsule once per day orally for 8 weeks
Drug: Placebo oral capsule
sugar capsule manufactured to mimic vitamin E capsule once per day
Other Name: Placebo

Primary Outcome Measures :
  1. Isoprostane (oxidative stress) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: 8 weeks ]

  2. LDL Cholesterol [ Time Frame: 8 weeks ]

  3. HDL Cholesterol [ Time Frame: 8 weeks ]

  4. Triglycerides [ Time Frame: 8 weeks ]

  5. Body weight [ Time Frame: 8 weeks ]

  6. Body Height [ Time Frame: 8 weeks ]

  7. BMI [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Obesity BMI ≥ p95 (CDC growth curve)

Exclusion Criteria:

  • Consuming antioxidants drug regularly within recruiting time
  • Consuming Orlistat

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03358524

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SMA Labschool
Jakarta, Indonesia, 13220
Sponsors and Collaborators
Indonesia University

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Responsible Party: Ali Alhadar, Pediatric Fellowship at Pediatric Nutrition and Metabolic disease, Indonesia University Identifier: NCT03358524     History of Changes
Other Study ID Numbers: 001
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents