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NCT02117700 · ClinicalTrials.gov registry record · Phase 1
Fatty Liver Disease in Obese Children
A Phase 1 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02117700: Completed Phase 1 study, sponsored by Nemours Children's Clinic.
NCT02117700 is a Phase 1 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02117700, a Phase 1 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
Although weight reduction through physical activity-based interventions is the mainstay therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and typically unsuccessful. This affirms the extreme need for alternate and/or adjunct therapies. Although convincing data from animal studies and a few adult human studies on the benefits of a natural product, N-acetyl cysteine (NAC), in a variety of liver conditions including NAFLD have emerged, studies in children are scarce. Therefore, the aim of the study is to test the use NAC as an innovative approach to attenuate the progression of NAFD in obese children with biopsy proven NASH. The central hypothesis is that NAC supplementation will reduce liver fat and liver enzymes and ameliorate risk factors of cardiometabolic disease in children with NAFLD.
Primary Outcome
The primary outcome will be sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 U/L or less and significant changes in liver fat (MRI) at the end of the study. All measurements of biological factors will be performed in the post absorptive (fasted) state.
Interventions
- DIETARY_SUPPLEMENT N-acetyl cysteine 600 mg once/day
- DIETARY_SUPPLEMENT N-acetyl cysteine 600mg twice/day
- OTHER Placebo twice/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-04 |
| Est. Completion | 2020-12 |
| Phase | Phase 1 |
What the finished NCT02117700 record still lists
NCT02117700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which N-acetyl cysteine 600 mg once/day is the first listed.
NCT02117700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02117700 about?
NCT02117700 is a clinical study titled "Fatty Liver Disease in Obese Children". Although weight reduction through physical activity-based interventions is the mainstay therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and typically unsuccessful. This affirms the extreme need for alternate and/or adjunct therapies. Although convincing data from a...
What is the current status of trial NCT02117700?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-04. Estimated completion is 2020-12.
What interventions are being tested in trial NCT02117700?
The interventions under investigation include: N-acetyl cysteine 600 mg once/day (DIETARY_SUPPLEMENT), N-acetyl cysteine 600mg twice/day (DIETARY_SUPPLEMENT), Placebo twice/day (OTHER).
Who is sponsoring clinical trial NCT02117700?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02117700's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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