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

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ClinicalTrials.gov Identifier: NCT02420496
Recruitment Status : Withdrawn
First Posted : April 17, 2015
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cholestasis Liver Disease Drug: Enteral fish oil Drug: Ursodeoxycholic Acid Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo (?) for the Treatment of Cholestasis in Infants
Study Start Date : June 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

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 Name: 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 Name: Actigall
Placebo Comparator: Placebo
Infant will receive placebo in two daily doses given enterally
Drug: Placebo
Other Name: Sterile Water



Primary Outcome Measures :
  1. Direct Bilirubin [ Time Frame: Evaluated every 7 days up to 180 days ]
    Direct bilirubin less than 1 mg/dL considered resolution of cholestasis



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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420496


Locations
United States, Texas
University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Cynthia Blanco, M.D. University of Texas

Publications:

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02420496     History of Changes
Other Study ID Numbers: HSC20150165H
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016

Keywords provided by The University of Texas Health Science Center at San Antonio:
Parental nutrition
associated

Additional relevant MeSH terms:
Liver Diseases
Cholestasis
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents