Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria

This study has been completed.
Sponsor:
Collaborator:
University of Texas
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00006142
First received: August 3, 2000
Last updated: June 23, 2005
Last verified: August 2000

August 3, 2000
June 23, 2005
December 1983
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Complete list of historical versions of study NCT00006142 on ClinicalTrials.gov Archive Site
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Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria
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OBJECTIVES:

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

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.

Interventional
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Primary Purpose: Prevention
Phenylketonuria
Behavioral: phenylalanine restricted diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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  • Women with diagnosis of phenylketonuria who are planning on becoming pregnant Slightly elevated phenylalanine level (hyperphe variant) allowed
Female
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00006142
199/15326, UTMB-83-188
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National Center for Research Resources (NCRR)
University of Texas
Study Chair: Bobbye M. Rouse University of Texas
Office of Rare Diseases (ORD)
August 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP