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

Sponsor:	University of Massachusetts, Worcester
Collaborator:	Cystic Fibrosis Foundation
Information provided by:	University of Massachusetts, Worcester
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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 Infant and Newborn Nutrition

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Sodium dehydroacetate

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

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 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Infants will be fed formula supplemented with docosahexaenoic acid	Dietary Supplement: Docosahexaenoic acid (DHA) Infant formula with 0.96% of fatty acids as DHA Other Name: LIPIL x 3
Placebo Comparator: 2 Infants will be fed standard formula (Enfamil)	Dietary Supplement: Standard formula (Enfamil) This is a standard, commercially available infant formula. Other Name: Enfamil

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

Locations

United States, Alabama
UAB/CHS Cystic Fibrosis Center
Birmingham, Alabama, United States, 35233
United States, Georgia
Emory Cystic Fibrosis Center
Atlanta, Georgia, United States, 30322
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
United States, Kansas
Cystic Fibrosis Care & Teaching Center
Wichita, Kansas, United States, 67218
United States, Kentucky
Kosair Charities
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
UMass Memorial Healthcare
Worcester, Massachusetts, United States, 01655
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
The Respiratory Center for Children
Morristown, New Jersey, United States, 07962-1956
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Children's Hospital
Buffalo, New York, United States, 14222
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
Strong Memorial Hospital
Rochester, New York, United States, 14642
Univesity Medical Center
Stony Brook, New York, United States, 11794
SUNY Upstate Medical Center
Syracuse, New York, United States, 13210
Children's Hospital at Westchester Medical Center
Valhalla, New York, United States, 10595
United States, Ohio
Lewis H Walker Cystic Fibrosis Center Division of Pulmonary
Akron, Ohio, United States, 44308
Lewis H Walker CF Pulmonary Center
Akron, Ohio, United States, 44308
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15231
United States, West Virginia
Mountain State University
Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

University of Massachusetts, Worcester

Cystic Fibrosis Foundation

Investigators

Principal Investigator:

Brian P O'Sullivan, MD

University of Massachusetts, Worcester

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:	Brian P O'Sullivan, MD/Principal Investigator, University of Massachusetts Medical School
ClinicalTrials.gov Identifier:	NCT00530244 History of Changes
Other Study ID Numbers:	OSULLI03A0, H-10721
Study First Received:	September 13, 2007
Last Updated:	January 18, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:

cystic fibrosis
fatty acids
docosahexaenoic acid

infant formula
growth
pancreatic function

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases

Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012