Use of Formula Fortified With DHA in Infants With Cystic Fibrosis - Full Text View

Sponsor:	University of Massachusetts
Collaborator:	Cystic Fibrosis Foundation
Information provided by:	University of Massachusetts
ClinicalTrials.gov Identifier:	NCT00530244

Purpose

The hypothesis of this study is that feeding infants diagnosed with CF via newborn screening a formula enhanced with a specific fish-oil fatty acid known as DHA will improve growth and decrease pancreatic dysfunction (as measured by human fecal elastase-1 in stool) over the first year of life.

Briefly, infants diagnosed with CF in the first month of life whose parents chose not to breast feed their babies will be invited to enroll in a study comparing a standard commercial infant formula (Enfamil) with a formula enriched with arachidonic acid (AA) and docosahexaenoic acid (DHA). The study formula has 3 times the amount of DHA available in commercially available formulas. Infants will have monthly tests of stool elastase and blood work at entry, 3, 6, 9 and 12 months of age.

Condition	Intervention	Phase
Cystic Fibrosis	Dietary Supplement: Docosahexaenoic acid (DHA) Dietary Supplement: Standard formula (Enfamil)	Phase II Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Formula Fortified With Docosahexaenoic Acid (DHA) on Infants With Cystic Fibrosis (CF)

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Bowel Movement Cystic Fibrosis Dietary Supplements Diets Infant and Toddler Nutrition

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by University of Massachusetts:

Primary Outcome Measures:

height and weight for age z-score and human fecal elastase-1 in stool [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary End Points: 1. AA/DHA ratio in plasma 2. Chest x-ray film Brasfield scores 3. Serum immune reactive trypsinogen 4. Serum alpha fetoprotein 5. Infant pulmonary function tests (subset analysis) 6. Bayley's scales of childhood development [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	March 2003
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Infants will be fed formula supplemented with docosahexaenoic acid	Dietary Supplement: Docosahexaenoic acid (DHA) Infant formula with 0.96% of fatty acids as DHA
2: Placebo Comparator Infants will be fed standard formula (Enfamil)	Dietary Supplement: Standard formula (Enfamil) This is a standard, commercially available infant formula.

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 56 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infant diagnosed with CF and enrolled by 56 days of life
Parental consent obtained

Exclusion Criteria:

History of meconium ileus at birth that is resolved without surgical intervention (ie enema)
History of bowel resection for any reason
Breast feeding
Premature birth (<34 weeks gestation)
Severe cholestasis (Direct Bilirubin > 2x upper limit of normal for age)
Severe hypoalbuminemia (Albumin < 2.5 gm/dl)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530244

Contacts

Contact: Brian P O'Sullivan, MD	508-856-4155	osullivb@ummhc.org
Contact: Dawn Baker, PNP	508-856-4155	dawn.baker@umassmed.edu

Locations

United States, Alabama
UAB/CHS Cystic Fibrosis Center	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Staci Thrasher 205-939-5494 sthrasher@peds.uab.edu
Principal Investigator: Hector Gutierrez, MD
United States, Florida
University of Florida Pediatric Pulmonary Center	Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Pamela Schuler schulpm@peds.ufl.edu
Principal Investigator: Pamela Schuler, MD
United States, Iowa
Blank Children's Hospital	Recruiting
Des Moines, Iowa, United States, 50309
Contact: Kathleen Gradoville 515-208-7895 GRADOVKM@ihs.org
Principal Investigator: Scott Sheets, MD
United States, Kansas
Cystic Fibrosis Care & Teaching Center	Recruiting
Wichita, Kansas, United States, 67218
Contact: Sheri Miller 316-268-6028 sheri_miller@viachristi.org
Principal Investigator: Maria Riva, MD
United States, Massachusetts
UMass Memorial Healthcare	Recruiting
Worcester, Massachusetts, United States, 01655
Principal Investigator: Brian P O'Sullivan, MD
Children's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Summer Gully 617-355-7881 summer.adams@childrens.harvard.edu
Principal Investigator: Terry L Spencer, MD
Baystate Medical Center	Recruiting
Springfield, Massachusetts, United States, 01199
Principal Investigator: Robert Gerstle, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dell Saulnier 617-726-3719 ddsaulnier@partners.org
Principal Investigator: Allen Lapey, MD
United States, New Jersey
Monmouth Medical Center	Recruiting
Long Branch, New Jersey, United States, 07740
Contact: Bridget Marra 732-222-4474 bmarra@sbhcs.com
Principal Investigator: Robert Zanni, MD
The Respiratory Center for Children	Active, not recruiting
Morristown, New Jersey, United States, 07962-1956
United States, New York
Albany Medical Center	Recruiting
Albany, New York, United States, 12208
Contact: Michelle VonSupton 518-262-6880 vonsutm@mail.amc.edu
Principal Investigator: Paul Comber, MD
Long Island College Hospital	Not yet recruiting
Brooklyn, New York, United States, 11201
Principal Investigator: Robert Giusti, MD
Children's Hospital	Recruiting
Buffalo, New York, United States, 14222
Contact: Nadine Caci 716-878-7561 ncaci@upa.chob.edu
Principal Investigator: Drucy Borowitz, MD
Schneider Children's Hospital	Recruiting
New Hyde Park, New York, United States, 11040
Contact: Lynn Bonitz 516-622-5282
Principal Investigator: Joan Germana, MD
St. Vincent's Catholic Medical Center	Not yet recruiting
New York, New York, United States, 10011
Principal Investigator: Maria Berdella, MD
Strong Memorial Hospital	Recruiting
Rochester, New York, United States, 14642
Contact: Marissa Dixon marissa_dixon@urmc.rochester.edu
Principal Investigator: Clement Ren, MD
Univesity Medical Center	Recruiting
Stony Brook, New York, United States, 11794
Contact: teresa carney 631-444-8340 teresa.carney@stonybrook.edu
Principal Investigator: Catherine Tayag-Kier, MD
SUNY Upstate Medical Center	Recruiting
Syracuse, New York, United States, 13210
Contact: Donna Lindner 315-464-6323 lindnerd@upstate.edu
Principal Investigator: Ran Anbar, MD
Children's Hospital at Westchester Medical Center	Recruiting
Valhalla, New York, United States, 10595
Contact: Ingrid Gherson 914-594-3320 ingrid_gherson@nymc.edu
Principal Investigator: Allen Dozer, MD
United States, Ohio
Lewis H Walker Cystic Fibrosis Center Division of Pulmonary	Recruiting
Akron, Ohio, United States, 44308
Contact: Debbie Ouelette 330-543-3089 douellette@chmca.org
Principal Investigator: Nathan C Kraynack, MD
United States, Pennsylvania
St. Christopher's Hospital for Children	Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Justin OverCash 215-427-3816 justin.overcash@tenethealth.com
Principal Investigator: Laurie Varlotta, MD
Children's Hospital of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15231
Contact: elizabeth hartigan 412-692-5677 elizabeth.hartigan@chp.edu
Contact: Judy Fulton 412-692-5677 judy.fulton@chp.edu
Principal Investigator: Peter Michelson, MD

Sponsors and Collaborators

University of Massachusetts

Cystic Fibrosis Foundation

Investigators

Principal Investigator:

Brian P O'Sullivan, MD

University of Massachusetts Medical School

More Information

Publications:

Freedman SD, Katz MH, Parker EM, Laposata M, Urman MY, Alvarez JG. A membrane lipid imbalance plays a role in the phenotypic expression of cystic fibrosis in cftr(-/-) mice. Proc Natl Acad Sci U S A. 1999 Nov 23;96(24):13995-4000.

Freedman SD, Blanco PG, Zaman MM, Shea JC, Ollero M, Hopper IK, Weed DA, Gelrud A, Regan MM, Laposata M, Alvarez JG, O'Sullivan BP. Association of cystic fibrosis with abnormalities in fatty acid metabolism. N Engl J Med. 2004 Feb 5;350(6):560-9.

Parker EM, O'Sullivan BP, Shea JC, Regan MM, Freedman SD. Survey of breast-feeding practices and outcomes in the cystic fibrosis population. Pediatr Pulmonol. 2004 Apr;37(4):362-7.

Walkowiak J, Herzig KH, Strzykala K, Przyslawski J, Krawczynski M. Fecal elastase-1 is superior to fecal chymotrypsin in the assessment of pancreatic involvement in cystic fibrosis. Pediatrics. 2002 Jul;110(1 Pt 1):e7.

Responsible Party:	University of Massachusetts Medical School ( Brian P O'Sullivan, MD/Principal Investigator )
Study ID Numbers:	OSULLI03A0, H-10721
Study First Received:	September 13, 2007
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00530244 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Massachusetts:

cystic fibrosis
fatty acids
docosahexaenoic acid

infant formula
growth
pancreatic function

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 30, 2009