Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of Phenylketonuria

Completed · Not applicable

Conditions studied: Phenylketonuria

In brief

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.

Key facts

Study ID

NCT01428258

Run by

University of Wisconsin, Madison

People needed

32

Starts

2011-09-01

Expected to finish

2016-05-01

Last updated by the study team

2018-08-24

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Identified PKU by newborn screening; started diet treatment before 1 mo age
• Diagnosis of classical or variant PKU with documented phenylalanine level of greater than 600 umol/L at 7-10d of age
• Follows or willing to follow PKU diet and consume amino acid medical formula providing more than 50% of protein needs
• Acceptance of glycomacropeptide foods determined prior to enrollment

You may not qualify if…

• Females who are pregnant or planning pregnancy
• Individuals with mental deficits due to untreated or poorly controlled PKU
• Individuals with any health condition deemed to interfere with participation

Where it is running

• Children's Hospital of Boston — Boston, Massachusetts, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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