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NCT00530244 · ClinicalTrials.gov registry record · NA

Use of Formula Fortified With DHA in Infants With Cystic Fibrosis

A NA study, sponsored by University of Massachusetts, Worcester.

Completed
Registry status
NA
Development phase
76
Enrollment target

NCT00530244 is a NA study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 76 participants.

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The verdict

NCT00530244, a NA study, has completed, sponsored by University of Massachusetts, Worcester.

COMPLETED
Registry status
NA
Development phase
76 participants
Enrollment target

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.

Interventions

  • DIETARY_SUPPLEMENT Docosahexaenoic acid (DHA)
  • DIETARY_SUPPLEMENT Standard formula (Enfamil)

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2003-03
Est. Completion 2011-10
Phase NA

What the Registry Record Tells You About NCT00530244

The ClinicalTrials.gov registry entry for NCT00530244 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Docosahexaenoic acid (DHA) is the first listed.

NCT00530244 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00530244 about?

NCT00530244 is a clinical study titled "Use of Formula Fortified With DHA in Infants With Cystic Fibrosis". 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. Brie...

What is the current status of trial NCT00530244?

This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2003-03. Estimated completion is 2011-10.

What interventions are being tested in trial NCT00530244?

The interventions under investigation include: Docosahexaenoic acid (DHA) (DIETARY_SUPPLEMENT), Standard formula (Enfamil) (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00530244?

This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.