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Use of Formula Fortified With DHA in Infants With Cystic Fibrosis
This study is currently recruiting participants.
Verified by University of Massachusetts, December 2008
First Received: September 13, 2007   Last Updated: December 4, 2008   History of Changes
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:


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:
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