- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006142
Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria
OBJECTIVES:
I. Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in offspring of patients with phenylketonuria.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PROTOCOL OUTLINE: This is a multicenter study.
Patients receive a phenylalanine restricted diet based on a medical food such as Phenyl-free, Lofenalac, PKU 3, or Maximum XP (may be supplemented with tyrosine as needed) to achieve a target blood phenylalanine level of 2-6 mg/dL. The diet begins approximately 3 months prior to conception and continues until delivery of the baby. Patients are evaluated once a month before conception and weekly during pregnancy. Patients also undergo sonographic examination at 8, 20, 28, and 34 weeks gestation. At birth, the cord blood is evaluated for plasma amino acids. If the baby is found to have an elevated phenylalanine level, blood and urine are obtained to determine the baby's genetic status. Phenylalanine and tyrosine levels are checked in the baby daily for three days after birth.
The baby is followed for physical and mental development at 3 and 6 months and then annually thereafter.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Women with diagnosis of phenylketonuria who are planning on becoming pregnant Slightly elevated phenylalanine level (hyperphe variant) allowed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Bobbye M. Rouse, University of Texas
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/15326
- UTMB-83-188
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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