Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo for the Treatment of Cholestasis in Infants

June 20, 2016 updated by: The University of Texas Health Science Center at San Antonio

Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo (?) for the Treatment of Cholestasis in Infants

To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution and other markers of parenteral nutrition-associated liver disease.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital (UH) in San Antonio, Texas, who:

  1. Are >14 days old and <24 months of age
  2. Have a serum direct bilirubin of ≥2 mg/dL
  3. Are receiving <3 g/k/day of Intralipid via TPN
  4. Are expected to remain hospitalized for at least an additional 21 days

Exclusion Criteria:

  1. Have a congenitally lethal condition (e.g. Trisomy 13)
  2. Have clinically severe bleeding not able to be managed with routine measures
  3. Have evidence of a viral hepatitis or primary liver disease as the etiology of their cholestasis
  4. Have other health problems such that survival is extremely unlikely even if cholestasis improves
  5. Known allergy to eggs or fish products
  6. Receiving IV Fish oil
  7. Phenobarbital therapy at enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enteral fish oil
Infants will receive enteral fish oil at a dose of 1mg/kg/day divided in two daily doses given enterally.
Drug: Enteral fish oil
Other Names:
  • Nordic Natural Omega 3
Active Comparator: UDCA (ursodeoxycholic acid)
Infants will receive UDCA at a dose of 10mg/kg/dose in two daily doses given enterally
Drug: Ursodeoxycholic Acid
Other Names:
  • Actigall
Placebo Comparator: Placebo
Infant will receive placebo in two daily doses given enterally
Drug: Placebo
Other Names:
  • Sterile Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct Bilirubin
Time Frame: Evaluated every 7 days up to 180 days
Direct bilirubin less than 1 mg/dL considered resolution of cholestasis
Evaluated every 7 days up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Cynthia Blanco, M.D., University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20150165H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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