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Search / Trial NCT00530244

Use of Formula Fortified With DHA in Infants With Cystic Fibrosis

Launched by UNIVERSITY OF MASSACHUSETTS, WORCESTER · Sep 13, 2007

Trial Information

Current as of April 27, 2025

Completed

Keywords

Cystic Fibrosis Fatty Acids Docosahexaenoic Acid Infant Formula Growth Pancreatic Function

ClinConnect Summary

This study brings together several areas of CF and non-CF research: the finding that CF knock-out mice exhibit an abnormality in AA/DHA ratio in membrane bound fatty acids from tissue which expresses CFTR; the fact that very high doses of DHA fed to CF knock-out mice can correct many of the abnormalities seen in these animals; research on fatty acid content in human breast milk; the effects of breast feeding in CF; and the fact that newborn screening for CF is becoming more widespread and may allow for therapeutic interventions very early in life. This is the first study of which we are awa...

Gender

ALL

Eligibility 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)

About University Of Massachusetts, Worcester

The University of Massachusetts Worcester is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the university integrates cutting-edge scientific inquiry with a commitment to improving patient outcomes. Its collaborative approach engages a diverse range of experts, fostering interdisciplinary research that addresses pressing health challenges. With a focus on ethical standards and regulatory compliance, the University of Massachusetts Worcester plays a pivotal role in translating scientific discoveries into practical applications that enhance medical practice and patient care.

Locations

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

Boston, Massachusetts, United States

Kansas City, Missouri, United States

Long Branch, New Jersey, United States

Des Moines, Iowa, United States

New Hyde Park, New York, United States

Albany, New York, United States

Rochester, New York, United States

Philadelphia, Pennsylvania, United States

Syracuse, New York, United States

Birmingham, Alabama, United States

Atlanta, Georgia, United States

Wichita, Kansas, United States

Louisville, Kentucky, United States

Worcester, Massachusetts, United States

Morristown, New Jersey, United States

Buffalo, New York, United States

Stony Brook, New York, United States

Valhalla, New York, United States

Akron, Ohio, United States

Akron, Ohio, United States

Pittsburgh, Pennsylvania, United States

Morgantown, West Virginia, United States

Patients applied

0 patients applied

Trial Officials

Brian P O'Sullivan, MD

Principal Investigator

University of Massachusetts, Worcester

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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