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

Primary Purpose

Cholestasis, Liver Disease

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Enteral fish oil

Ursodeoxycholic Acid

Placebo

About this trial

This is an interventional treatment trial for Cholestasis focused on measuring Parental nutrition, associated

Eligibility Criteria

14 Days - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Exclusion Criteria:

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

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Enteral fish oil

UDCA (ursodeoxycholic acid)

Placebo

Arm Description

Infants will receive enteral fish oil at a dose of 1mg/kg/day divided in two daily doses given enterally.

Infants will receive UDCA at a dose of 10mg/kg/dose in two daily doses given enterally

Infant will receive placebo in two daily doses given enterally

Outcomes

Primary Outcome Measures

Direct Bilirubin

Direct bilirubin less than 1 mg/dL considered resolution of cholestasis

Secondary Outcome Measures

Full Information

NCT ID

NCT02420496

First Posted

April 1, 2015

Last Updated

June 20, 2016

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT02420496

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Withdrawn

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholestasis, Liver Disease

Keywords

Parental nutrition, associated

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enteral fish oil

Arm Type

Experimental

Arm Description

Infants will receive enteral fish oil at a dose of 1mg/kg/day divided in two daily doses given enterally.

Arm Title

UDCA (ursodeoxycholic acid)

Arm Type

Active Comparator

Arm Description

Infants will receive UDCA at a dose of 10mg/kg/dose in two daily doses given enterally

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Infant will receive placebo in two daily doses given enterally

Intervention Type

Drug

Intervention Name(s)

Enteral fish oil

Other Intervention Name(s)

Nordic Natural Omega 3

Intervention Type

Drug

Intervention Name(s)

Ursodeoxycholic Acid

Other Intervention Name(s)

Actigall

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sterile Water

Primary Outcome Measure Information:

Title

Direct Bilirubin

Description

Direct bilirubin less than 1 mg/dL considered resolution of cholestasis

Time Frame

Evaluated every 7 days up to 180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Days

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital (UH) in San Antonio, Texas, who: Are >14 days old and <24 months of age Have a serum direct bilirubin of ≥2 mg/dL Are receiving <3 g/k/day of Intralipid via TPN Are expected to remain hospitalized for at least an additional 21 days Exclusion Criteria: Have a congenitally lethal condition (e.g. Trisomy 13) Have clinically severe bleeding not able to be managed with routine measures Have evidence of a viral hepatitis or primary liver disease as the etiology of their cholestasis Have other health problems such that survival is extremely unlikely even if cholestasis improves Known allergy to eggs or fish products Receiving IV Fish oil Phenobarbital therapy at enrollment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cynthia Blanco, M.D.

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9437702

Citation

Kelly DA. Liver complications of pediatric parenteral nutrition--epidemiology. Nutrition. 1998 Jan;14(1):153-7. doi: 10.1016/s0899-9007(97)00232-3.

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Citation

Christensen RD, Henry E, Wiedmeier SE, Burnett J, Lambert DK. Identifying patients, on the first day of life, at high-risk of developing parenteral nutrition-associated liver disease. J Perinatol. 2007 May;27(5):284-90. doi: 10.1038/sj.jp.7211686. Epub 2007 Mar 8.

Results Reference

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PubMed Identifier

17208555

Citation

Nathan JD, Rudolph JA, Kocoshis SA, Alonso MH, Ryckman FC, Tiao GM. Isolated liver and multivisceral transplantation for total parenteral nutrition-related end-stage liver disease. J Pediatr Surg. 2007 Jan;42(1):143-7. doi: 10.1016/j.jpedsurg.2006.09.049.

Results Reference

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PubMed Identifier

11071594

Citation

Colomb V, Jobert-Giraud A, Lacaille F, Goulet O, Fournet JC, Ricour C. Role of lipid emulsions in cholestasis associated with long-term parenteral nutrition in children. JPEN J Parenter Enteral Nutr. 2000 Nov-Dec;24(6):345-50. doi: 10.1177/0148607100024006345.

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PubMed Identifier

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Citation

Javid PJ, Greene AK, Garza J, Gura K, Alwayn IP, Voss S, Nose V, Satchi-Fainaro R, Zausche B, Mulkern RV, Jaksic T, Bistrian B, Folkman J, Puder M. The route of lipid administration affects parenteral nutrition-induced hepatic steatosis in a mouse model. J Pediatr Surg. 2005 Sep;40(9):1446-53. doi: 10.1016/j.jpedsurg.2005.05.045.

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PubMed Identifier

16923311

Citation

Calder PC. Use of fish oil in parenteral nutrition: Rationale and reality. Proc Nutr Soc. 2006 Aug;65(3):264-77. doi: 10.1079/pns2006500.

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PubMed Identifier

9437703

Citation

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Citation

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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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