Low Phenylalanine Diet for Mothers With Phenylketonuria (PKU) (NCT00065299) | Clinical Trial Compass
CompletedNot Applicable
Low Phenylalanine Diet for Mothers With Phenylketonuria (PKU)
United States572 participantsStarted 1984-05
Plain-language summary
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.
Who can participate
Age range0 Years
SexFEMALE
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Inclusion Criteria
* 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
Exclusion Criteria
* Women with evidence of pterin defect
Trial details
NCT IDNCT00065299
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)