Status:
COMPLETED
Study of BH4, a New and Simple Treatment of Mild PKU
Lead Sponsor:
The Kennedy Institute-National Eye Clinic
Collaborating Sponsors:
Sygekassernes Helsefond
Conditions:
Phenylketonuria
Eligibility:
All Genders
8+ years
Phase:
PHASE2
Brief Summary
The main purpose is to test whether treatment with BH4-tablets can replace the protein restrictive diet in patients with mild PKU caused by a certain frequent mutation.
Detailed Description
PKU, phenylketonuria, is a rare, inherited metabolic disorder that results in mental retardation if not a very strict low-protein diet is started within the first weeks of life. The conversion of phe...
Eligibility Criteria
Inclusion
- Diagnosed mild PKU with 2 known mutations in the PAH gene, hereof at least one Y414C From the age of eight Informed consent -
Exclusion
- Less than 8 years of age Pregnancy or treated with the intensive diet of pregnancy
- \-
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00260000
Start Date
April 1 2005
End Date
December 1 2005
Last Update
April 13 2006
Active Locations (1)
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1
The Kennedy Institute-National Eye Clinic
Glostrup Municipality, Copenhagen, Denmark, DK-2600