NCT03358524

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

November 25, 2017

Last Update Submit

March 1, 2018

Conditions

Obesity, AdolescentOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • Isoprostane (oxidative stress)

    pg/ml

    8 weeks

Secondary Outcomes (7)

  • Total Cholesterol

    8 weeks

  • LDL Cholesterol

    8 weeks

  • HDL Cholesterol

    8 weeks

  • Triglycerides

    8 weeks

  • Body weight

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Vitamin E 400 IU

EXPERIMENTAL

Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks

Drug: Vitamin E 400 UNT

Placebo

PLACEBO COMPARATOR

Placebo capsule once per day orally for 8 weeks

Drug: Placebo oral capsule

Interventions

Vitamin E 400 UNTDRUG

Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)

Also known as: Vitamin E
Vitamin E 400 IU
Placebo oral capsuleDRUG

sugar capsule manufactured to mimic vitamin E capsule once per day

Also known as: Placebo
Placebo

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Obesity BMI ≥ p95 (CDC growth curve)

You may not qualify if:

  • Consuming antioxidants drug regularly within recruiting time
  • Consuming Orlistat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMA Labschool

Jakarta, 13220, Indonesia

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Fellowship at Pediatric Nutrition and Metabolic disease

Study Record Dates

First Submitted

November 25, 2017

First Posted

November 30, 2017

Study Start

September 28, 2017

Primary Completion

February 20, 2018

Study Completion

March 1, 2018

Last Updated

March 2, 2018

Record last verified: 2018-03

Locations

ID(1)