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

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02420496
• Other study ID #: HSC20150165H
• Status: Withdrawn
• Phase: Phase 2
• First received: April 1, 2015
• Last updated: June 20, 2016
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Liver Disease
• Liver Diseases

Intervention

Drug:
• Enteral fish oil

• Ursodeoxycholic Acid

• Placebo

Locations

Country	Name	City	State
United States	University Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (14)

Alwayn IP, Andersson C, Zauscher B, Gura K, Nosé V, Puder M. Omega-3 fatty acids improve hepatic steatosis in a murine model: potential implications for the marginal steatotic liver donor. Transplantation. 2005 Mar 15;79(5):606-8. — View Citation

Calder PC. Use of fish oil in parenteral nutrition: Rationale and reality. Proc Nutr Soc. 2006 Aug;65(3):264-77. Review. — View Citation

Chen CY, Tsao PN, Chen HL, Chou HC, Hsieh WS, Chang MH. Ursodeoxycholic acid (UDCA) therapy in very-low-birth-weight infants with parenteral nutrition-associated cholestasis. J Pediatr. 2004 Sep;145(3):317-21. — View 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. Epub 2007 Mar 8. — View Citation

Clayton PT, Whitfield P, Iyer K. The role of phytosterols in the pathogenesis of liver complications of pediatric parenteral nutrition. Nutrition. 1998 Jan;14(1):158-64. Review. — View 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. — View Citation

Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86. doi: 10.1542/peds.2007-2248. — View 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. — View Citation

Kelly DA. Liver complications of pediatric parenteral nutrition--epidemiology. Nutrition. 1998 Jan;14(1):153-7. Review. — View 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. — View Citation

Premkumar MH, Carter BA, Hawthorne KM, King K, Abrams SA. Fish oil-based lipid emulsions in the treatment of parenteral nutrition-associated liver disease: an ongoing positive experience. Adv Nutr. 2014 Jan 1;5(1):65-70. doi: 10.3945/an.113.004671. Review. — View Citation

Thibault M, McMahon J, Faubert G, Charbonneau J, Malo J, Ferreira E, Mohamed I. Parenteral nutrition-associated liver disease: a retrospective study of ursodeoxycholic Acid use in neonates. J Pediatr Pharmacol Ther. 2014 Jan;19(1):42-8. doi: 10.5863/1551-6776-19.1.42. — View Citation

Tillman EM, Crill CM, Black DD, Hak EB, Lazar LF, Christensen ML, Huang EY, Helms RA. Enteral fish oil for treatment of parenteral nutrition-associated liver disease in six infants with short-bowel syndrome. Pharmacotherapy. 2011 May;31(5):503-9. doi: 10.1592/phco.31.5.503. — View Citation

Yang Q, Ayers K, Welch CD, O'Shea TM. Randomized controlled trial of early enteral fat supplement and fish oil to promote intestinal adaptation in premature infants with an enterostomy. J Pediatr. 2014 Aug;165(2):274-279.e1. doi: 10.1016/j.jpeds.2014.02.002. Epub 2014 Mar 12. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct Bilirubin	Direct bilirubin less than 1 mg/dL considered resolution of cholestasis	Evaluated every 7 days up to 180 days	No