Study of BH4, a New and Simple Treatment of Mild PKU
NCT00260000 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2006-04-13
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.
Conditions
Interventions
- DRUG
-
5,6,7,8-tetrahydrobiopterin
Sponsors & Collaborators
-
Sygekassernes Helsefond
collaborator OTHER -
The Kennedy Institute-National Eye Clinic
lead OTHER_GOV
Principal Investigators
-
Jytte B Nielsen, DMSc · The Kennedy Institute-National Eye Clinic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Completion
- 2005-12-31
Countries
- Denmark
Study Locations
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