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



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

For Condition: Phenylketonuria
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Texas
Synopsis: OBJECTIVES: I. Assess the impact of a phenylalanine restricted diet during pregnancy on symptoms in offspring of patients with phenylketonuria.
Details: 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.
Eligibility:
Study Type:
  Interventional, Prevention
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: - Women with diagnosis of phenylketonuria who are planning on becoming pregnant Slightly elevated phenylalanine level (hyperphe variant) allowed
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BobbyeRouse,  Study Chair,  University of Texas


Additional Information:
Study ID Numbers:
  199/15326;  UTMB-83-188
Study Start Date: December 1983
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006142

Other Phenylketonuria Studies:
1. Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria

2. Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU)

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