Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT01428258
Eligibility Criteria:
Inclusion Criteria:
* Identified PKU by newborn screening; started diet treatment before 1 mo age
* Diagnosis of classical or variant PKU with documented phenylalanine level of greater than 600 umol/L at 7-10d of age
* Follows or willing to follow PKU diet and consume amino acid medical formula providing more than 50% of protein needs
* Acceptance of glycomacropeptide foods determined prior to enrollment
Exclusion Criteria:
* Females who are pregnant or planning pregnancy
* Individuals with mental deficits due to untreated or poorly controlled PKU
* Individuals with any health condition deemed to interfere with participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
45 Years
Study:
NCT01428258
Study Brief:
Protocol Section:
NCT01428258