Use of Formula Fortified With DHA in Infants With Cystic Fibrosis
DHA
The Effect of Formula Fortified With Docosahexaenoic Acid (DHA) on Infants With Cystic Fibrosis (CF)
2 other identifiers
interventional
76
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2003
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2007
CompletedFirst Posted
Study publicly available on registry
September 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMarch 7, 2018
March 1, 2018
8.6 years
September 13, 2007
March 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
height and weight for age z-score and human fecal elastase-1 in stool
one year
Secondary Outcomes (1)
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
1 year
Study Arms (2)
1
EXPERIMENTALInfants will be fed formula supplemented with docosahexaenoic acid
2
PLACEBO COMPARATORInfants will be fed standard formula (Enfamil)
Interventions
Infant formula with 0.96% of fatty acids as DHA
This is a standard, commercially available infant formula.
Eligibility Criteria
You may qualify if:
- Infant diagnosed with CF and enrolled by 56 days of life
- Parental consent obtained
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Worcesterlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (24)
UAB/CHS Cystic Fibrosis Center
Birmingham, Alabama, 35233, United States
Emory Cystic Fibrosis Center
Atlanta, Georgia, 30322, United States
Blank Children's Hospital
Des Moines, Iowa, 50309, United States
Cystic Fibrosis Care & Teaching Center
Wichita, Kansas, 67218, United States
Kosair Charities
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Children's Hospital
Boston, Massachusetts, 02115, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
UMass Memorial Healthcare
Worcester, Massachusetts, 01655, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
The Respiratory Center for Children
Morristown, New Jersey, 07962-1956, United States
Albany Medical Center
Albany, New York, 12208, United States
Children's Hospital
Buffalo, New York, 14222, United States
Schneider Children's Hospital
New Hyde Park, New York, 11040, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Univesity Medical Center
Stony Brook, New York, 11794, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
Children's Hospital at Westchester Medical Center
Valhalla, New York, 10595, United States
Lewis H Walker CF Pulmonary Center
Akron, Ohio, 44308, United States
Lewis H Walker Cystic Fibrosis Center Division of Pulmonary
Akron, Ohio, 44308, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15231, United States
Mountain State University
Morgantown, West Virginia, 26506, United States
Related Publications (5)
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. doi: 10.1073/pnas.96.24.13995.
PMID: 10570187BACKGROUNDFreedman 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. doi: 10.1056/NEJMoa021218.
PMID: 14762183BACKGROUNDParker 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. doi: 10.1002/ppul.10450.
PMID: 15022134BACKGROUNDWalkowiak 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. doi: 10.1542/peds.110.1.e7.
PMID: 12093988BACKGROUNDO'Sullivan BP, Baker D, Leung KG, Reed G, Baker SS, Borowitz D. Evolution of pancreatic function during the first year in infants with cystic fibrosis. J Pediatr. 2013 Apr;162(4):808-812.e1. doi: 10.1016/j.jpeds.2012.10.008. Epub 2012 Dec 11.
PMID: 23245194DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian P O'Sullivan, MD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2007
First Posted
September 17, 2007
Study Start
March 1, 2003
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
March 7, 2018
Record last verified: 2018-03