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  

ChemIDplus related topics:   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    
Contact: Brian P O'Sullivan, MD     508-856-4155     osullivb@ummhc.org    
Contact: Dawn Baker, PNP     508-856-4155     dawn.baker@umassmed.edu    
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            
University of Massachusetts
Cystic Fibrosis Foundation
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:
Cystic Fibrosis
Fibrosis
Lung Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Infant, Newborn, Diseases
Cystic Fibrosis

Source: National Library of Medicine (NLM) July 03, 2008

  


 
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