Status:
COMPLETED
Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of Phenylketonuria
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Phenylketonuria
Eligibility:
All Genders
12-45 years
Phase:
NA
Brief 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 complian...
Detailed Description
Individuals with phenylketonuria (PKU) lack the enzyme phenylalanine hydroxylase that is needed to metabolize the essential amino acid phenylalanine (phe). When eating a normal diet they show an eleva...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01428258
Start Date
September 1 2011
End Date
May 1 2016
Last Update
August 24 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115
2
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53706