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NCT00512629 · ClinicalTrials.gov registry record · Phase 1
Cholestasis Prevention: Efficacy of IV Fish Oil
A Phase 1 study of Cholestasis and Parenteral Nutrition, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00512629 is a Phase 1 study of Cholestasis and Parenteral Nutrition that has completed, run by Boston Children's Hospital. The registered enrollment target is 19 participants, below the 155-participant average among 6 other Cholestasis trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00512629, a Phase 1 study of Cholestasis and Parenteral Nutrition, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury that may ultimately result in hepatic failure. In studies conducted in a murine model, we observed that intravenous fat emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of cholestasis, a common precursor of PN-associated liver disease, as well as reverse preexisting PNALD through a combination of factors, including improved triglyceride clearance coupled with anti-inflammatory properties. In a case series treating patients with hepatic cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no adverse reactions attributed to its use were observed. Based on results of these previous studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal failure
Conditions Studied
Interventions
- DRUG Intralipid
- DRUG Omegaven
Study Locations (1)
Massachusetts
- Childrens's Hospital Boston - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2007-07 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00512629
The ClinicalTrials.gov registry entry for NCT00512629 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 155-participant average among 6 other Cholestasis trials with a reported enrollment target (88% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cholestasis appearing as the primary indexed condition, and to 2 interventions - of which Intralipid is the first listed.
NCT00512629 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00512629 about?
NCT00512629 is a clinical study titled "Cholestasis Prevention: Efficacy of IV Fish Oil". Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury that may ultimately result in hepatic failure. In studies conducted in a ...
What is the current status of trial NCT00512629?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2007-07. Estimated completion is 2011-12.
What conditions does trial NCT00512629 study?
This clinical trial studies the following conditions: Cholestasis, Parenteral Nutrition.
What interventions are being tested in trial NCT00512629?
The interventions under investigation include: Intralipid (DRUG), Omegaven (DRUG).
Who is sponsoring clinical trial NCT00512629?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00512629 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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