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Use of Formula Fortified With DHA in Infants With Cystic Fibrosis

NCT00530244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-03-07

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Docosahexaenoic acid (DHA)

Infant formula with 0.96% of fatty acids as DHA

DIETARY_SUPPLEMENT

Standard formula (Enfamil)

This is a standard, commercially available infant formula.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Brian P O'Sullivan, MD · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
56 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530244 on ClinicalTrials.gov