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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 is a Phase 1 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02117700
The ClinicalTrials.gov registry entry for NCT02117700 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which N-acetyl cysteine 600 mg once/day is the first listed.
NCT02117700 reports 0 study locations.
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.
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