Low Phenylalanine Diet for Mothers With Phenylketonuria (PKU)

Completed · Not applicable

Conditions studied: Phenylketonuria

In brief

Phenylketonuria (PKU) is a rare genetic condition. If not treated, PKU can cause severe mental retardation. Women with PKU are advised to eat a special diet when pregnant to prevent mental retardation in their children. This study will evaluate the effects of that diet on the children of mothers with PKU.

Key facts

Study ID

NCT00065299

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

572

Starts

1984-05-01

Expected to finish

2000-04-01

Last updated by the study team

2005-06-24

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Live in community setting
• Become pregnant or give birth during the term of the investigation
• Identified early in pregnancy
• Dietary therapy instituted prior to conception whenever possible
• Diagnosis of PKU based on results of Phe challenge, or clear diagnostic evidence in medical record
• Blood Phe > 4 mg/dl
• Intellectually able to understand and comply with the requirements of the Phe restricted diet, understand an informed consent, and adequately communicate with clinic personnel
• IQ > 70
• Inclusion Criteria for Controls
• Heterozygous sisters to HPA women
• Matched control from maternity facility; pregnancy and offspring from a non-PKU female and a PKU male

You may not qualify if…

• Women with evidence of pterin defect

Where it is running

• University of Southern California School of Medicine — Los Angeles, California, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Texas Medical Branch at Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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