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:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT02009904
Eligibility Criteria:
Inclusion Criteria:
Study Subjects:
1. Children (4-18y)diagnosed with PKU
2. Parent(s) or guardian(s) willing and able to provide informed signed consent.
3. Parent(s) or guardian(s) willing and able to comply with all study procedures
Healthy controls:
1. Healthy Children (4-18y) with no health condition
2. Willing to go through an initial screening for age and gender match
3. Parents or guardians willing and able to provide informed signed consent.
4. Parents or guardians willing and able to comply with study procedures
Exclusion Criteria:
Study Subjects:
1. Children \< 4y of age diagnosed with PKU, as it may be challenging to collect breath samples and perform indirect calorimeter in very young children
2. Children (4-18y)who are diagnosed with PKU, but are currently ill, with a fever, cold, vomiting or diarrhea
Healthy controls:
1. Healthy Children \< 4y of age , as it may be challenging to collect breath samples and perform indirect calorimeter in very young children.
2. Healthy Children (4-18y), but are currently ill, with a fever, cold, vomiting or diarrhea.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT02009904
Study Brief:
Protocol Section:
NCT02009904