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

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

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis Dietary Supplements Infant and Toddler Nutrition

Drug Information available for:

Docosahexaenoic acids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Official Title:	The Effect of Formula Fortified With Docosahexaenoic Acid (DHA) on Infants With Cystic Fibrosis (CF)

Further study details as provided by University of Massachusetts:

Primary Outcome Measures:

Primary End Points 1. Height and Weight for age z-score 2. Human Fecal Elastase-1 in stool [ Time Frame: 1 year ]

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 ]

Estimated Enrollment:	90
Study Start Date:	March 2003
Estimated Study Completion Date:	July 2009

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
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, 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
	Principal Investigator: Deb Boyer, MD
	Baystate Medical Center	Recruiting
	Springfield, Massachusetts, United States, 01199
	Principal Investigator: Robert Gerstle, MD
	Massachusetts General Hospital	Recruiting
	Boston, Massachusetts, United States, 02114
	Principal Investigator: Henry Dorkin, MD

United States, New Jersey
	Monmouth Medical Center	Recruiting
	Long Branch, New Jersey, United States, 07740
	Principal Investigator: Robert Zanni, MD

United States, New York
	Albany Medical Center	Recruiting
	Albany, New York, United States, 12208
	Principal Investigator: Paul Comber, MD
	Long Island College Hospital	Recruiting
	Brooklyn, New York, United States, 11201
	Principal Investigator: Robert Giusti, MD
	Children's Hospital	Recruiting
	Buffalo, New York, United States, 14222
	Principal Investigator: Drucy Borowitz, MD
	Schneider Children's Hospital	Recruiting
	New Hyde Park, New York, United States, 11040
	Principal Investigator: Joan Germana, MD
	St. Vincent's Catholic Medical Center	Recruiting
	New York, New York, United States, 10011
	Principal Investigator: Maria Berdella, MD
	Strong Memorial Hospital	Recruiting
	Rochester, New York, United States, 14642
	Principal Investigator: Clement Ren, MD
	Univesity Medical Center	Recruiting
	Stony Brook, New York, United States, 11794
	Principal Investigator: Catherine Tayag-Kier, MD
	SUNY Upstate Medical Center	Recruiting
	Syracuse, New York, United States, 13210
	Principal Investigator: Ran Anbar, MD
	Children's Hospital at Westchester Medical Center	Recruiting
	Valhalla, New York, United States, 10595
	Principal Investigator: Nikhil Amini, MD

United States, Pennsylvania
	St. Christopher's Hospital for Children	Recruiting
	Philadelphia, Pennsylvania, United States, 19134
	Principal Investigator: Laurie Varlotta, MD
	Children's Hospital of Pittsburgh	Recruiting
	Pittsburgh, Pennsylvania, United States, 15231
	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.

Study ID Numbers:	OSULLI03A0, H-10721
First Received:	September 13, 2007
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00530244
Health Authority:	United States: Cystic Fibrosis Foundation Therapeutics; United States: CFF DSMB; United States: Institutional Review Board

Keywords provided by University of Massachusetts:

cystic fibrosis

fatty acids

docosahexaenoic acid

infant formula

growth

pancreatic function

Study placed in the following topic categories:

Digestive System Diseases

Genetic Diseases, Inborn

Respiratory Tract Diseases

Cystic Fibrosis

Fibrosis

Lung Diseases

Infant, Newborn, Diseases

Pancreatic Diseases

Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	University of Massachusetts Cystic Fibrosis Foundation
Information provided by:	University of Massachusetts
ClinicalTrials.gov Identifier:	NCT00530244