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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00260000 on ClinicalTrials.gov