Use of Formula Fortified With DHA in Infants With Cystic Fibrosis (DHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00530244
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : March 7, 2018
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: Docosahexaenoic acid (DHA) Dietary Supplement: Standard formula (Enfamil) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Formula Fortified With Docosahexaenoic Acid (DHA) on Infants With Cystic Fibrosis (CF)
Study Start Date : March 2003
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. height and weight for age z-score and human fecal elastase-1 in stool [ Time Frame: one year ]

Secondary Outcome Measures :
  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 [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 56 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00530244

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
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Children's Hospital
Boston, Massachusetts, United States, 02115
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 CF Pulmonary Center
Akron, Ohio, United States, 44308
Lewis H Walker Cystic Fibrosis Center Division of Pulmonary
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 Therapeutics
Principal Investigator: Brian P O'Sullivan, MD University of Massachusetts, Worcester

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Massachusetts, Worcester Identifier: NCT00530244     History of Changes
Other Study ID Numbers: OSULLI03A0
H-10721 ( Other Identifier: UMass Worcester )
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Massachusetts, Worcester:
cystic fibrosis
fatty acids
docosahexaenoic acid
infant formula
pancreatic function

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