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

Primary Purpose

Phenylketonuria

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

phenylalanine restricted diet

About this trial

This is an interventional prevention trial for Phenylketonuria focused on measuring inborn errors of metabolism, phenylketonuria, rare disease

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006142

First Posted

August 3, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT00006142

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2000

Overall Recruitment Status

Completed

Study Start Date

December 1983 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Texas

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phenylketonuria

Keywords

inborn errors of metabolism, phenylketonuria, rare disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

phenylalanine restricted diet

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bobbye M. Rouse

Organizational Affiliation

University of Texas

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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