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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03358524
• Date of registration: 25/11/2017
• Prospective Registration: No
• Primary sponsor: Indonesia University
• Public title: Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia
• Scientific title: Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
• Date of first enrolment: September 28, 2017
• Target sample size: 69
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03358524
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Indonesia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Obesity BMI = p95 (CDC growth curve)

Exclusion Criteria:

- Consuming antioxidants drug regularly within recruiting time

- Consuming Orlistat



Age minimum: 14 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity, Adolescent

Oxidative Stress

Intervention(s)

Drug: Vitamin E 400 UNT

Drug: Placebo oral capsule

Primary Outcome(s)

Isoprostane (oxidative stress) [Time Frame: 8 weeks]

Secondary Outcome(s)

HDL Cholesterol [Time Frame: 8 weeks]

Triglycerides [Time Frame: 8 weeks]

Body weight [Time Frame: 8 weeks]

LDL Cholesterol [Time Frame: 8 weeks]

Total Cholesterol [Time Frame: 8 weeks]

BMI [Time Frame: 8 weeks]

Body Height [Time Frame: 8 weeks]

Secondary ID(s)

001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors