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.

Completed

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Key information

Conditions

Phenylketonuria Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phenylketonurias Rare Diseases

Age range

0 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Women with diagnosis of phenylketonuria who are planning on becoming pregnant Slightly elevated phenylalanine level (hyperphe variant) allowed

Treatment and study plan

phenylalanine restricted diet

Behavioral

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

University of Texas

Registry information

Important dates

Study start: 1983
First posted: Aug 4, 2000
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed