NCT00006142

Brief Summary

OBJECTIVES: I. Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in offspring of patients with phenylketonuria.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1983

Completed
16.7 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2000

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 2000

First QC Date

August 3, 2000

Last Update Submit

June 23, 2005

Conditions

Phenylketonuria

Keywords

inborn errors of metabolismphenylketonuriarare disease

Interventions

phenylalanine restricted dietBEHAVIORAL

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Women with diagnosis of phenylketonuria who are planning on becoming pregnant Slightly elevated phenylalanine level (hyperphe variant) allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

PhenylketonuriasMetabolism, Inborn ErrorsRare Diseases

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAmino Acid Metabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bobbye M. Rouse

    University of Texas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

August 3, 2000

First Posted

August 4, 2000

Study Start

December 1, 1983

Last Updated

June 24, 2005

Record last verified: 2000-08