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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: Completed NA study, sponsored by University of Wisconsin, Madison.
NCT01428258 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Plasma will be collected at each base week and after 3 weeks on each of the dietary treatments, glycomacropeptide and amino acid, following an overnight fast. Plasma phenylalanine concentration (along with the complete profile of free amino acids) will be determined with an amino acid analyzer in the Wisconsin State Lab of Hygiene. Statistical analysis to determine the significance of the change in plasma phe concentration when comparing the 2 diets will consist of ANCOVA with covariates for bas
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 |
What the finished NCT01428258 record still lists
NCT01428258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which GMP Diet/GMP Medical Foods is the first listed.
NCT01428258 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01428258's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 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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