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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: Completed NA study, sponsored by University of Massachusetts, Worcester.

NCT00530244 is a NA study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 76 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00530244 record still lists

NCT00530244 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

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

NCT00530244 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00530244's enrollment target sits among peer trials

76 1062nd of 2000 higher than 932 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00530244, the US trial registry maintained by the National Library of Medicine. NCT00530244 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.