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NCT01428258 · ClinicalTrials.gov registry record · NA
Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of Phenylketonuria
A NA study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT01428258 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 32 participants.
The verdict
NCT01428258, a NA study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
For individuals with Phenylketonuria (PKU), the investigators hypothesize that glycomacropeptide will provide an acceptable form of low-phenylalanine dietary protein that will improve dietary compliance, blood phenylalanine levels, cognitive function, and ultimately quality of life compared with the usual amino acid based diet. The study is funded by the Food and Drug Administration (FDA) Office of Orphan Products Development Grants Program, R01 FD003711.
Interventions
- OTHER GMP Diet/GMP Medical Foods
- OTHER AA Diet/AA Medical Foods
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01428258
The ClinicalTrials.gov registry entry for NCT01428258 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GMP Diet/GMP Medical Foods is the first listed.
NCT01428258 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01428258 about?
NCT01428258 is a clinical study titled "Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of Phenylketonuria". For individuals with Phenylketonuria (PKU), the investigators hypothesize that glycomacropeptide will provide an acceptable form of low-phenylalanine dietary protein that will improve dietary compliance, blood phenylalanine levels, cognitive function, and ultimately quality of life compared with the...
What is the current status of trial NCT01428258?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2011-09. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01428258?
The interventions under investigation include: GMP Diet/GMP Medical Foods (OTHER), AA Diet/AA Medical Foods (OTHER).
Who is sponsoring clinical trial NCT01428258?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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