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

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ClinicalTrials.gov Identifier: NCT03358524
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ali Alhadar, Indonesia University

Tracking Information
First Submitted Date  ICMJE November 25, 2017
First Posted Date  ICMJE November 30, 2017
Last Update Posted Date March 2, 2018
Actual Study Start Date  ICMJE September 28, 2017
Actual Primary Completion Date February 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2017)
Isoprostane (oxidative stress) [ Time Frame: 8 weeks ]
pg/ml
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2017)
Isoprostane (oxidative stress) [ Time Frame: 8 weeks ]
Isoprostane differences after vitamin E treatment
Change History Complete list of historical versions of study NCT03358524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2017)
  • Total Cholesterol [ Time Frame: 8 weeks ]
    mg/dl
  • LDL Cholesterol [ Time Frame: 8 weeks ]
    mg/dl
  • HDL Cholesterol [ Time Frame: 8 weeks ]
    mg/dl
  • Triglycerides [ Time Frame: 8 weeks ]
    mg/dl
  • Body weight [ Time Frame: 8 weeks ]
    kilograms
  • Body Height [ Time Frame: 8 weeks ]
    centimeters
  • BMI [ Time Frame: 8 weeks ]
    kg/m^2
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2017)
Lipid profile [ Time Frame: 8 weeks ]
differences in lipid profile after vitamin E treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia
Official Title  ICMJE Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity, Adolescent
  • Oxidative Stress
Intervention  ICMJE
  • Drug: Vitamin E 400 UNT
    Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)
    Other Name: Vitamin E
  • Drug: Placebo oral capsule
    sugar capsule manufactured to mimic vitamin E capsule once per day
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Vitamin E 400 IU
    Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks
    Intervention: Drug: Vitamin E 400 UNT
  • Placebo Comparator: Placebo
    Placebo capsule once per day orally for 8 weeks
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2018)
69
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2017)
70
Actual Study Completion Date  ICMJE March 1, 2018
Actual Primary Completion Date February 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obesity BMI ≥ p95 (CDC growth curve)

Exclusion Criteria:

  • Consuming antioxidants drug regularly within recruiting time
  • Consuming Orlistat
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03358524
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ali Alhadar, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Indonesia University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP