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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04302194
Eligibility Criteria:
Inclusion Criteria:
1. Infants with hyperphenylalaninemia on special formula and diet
2. Infants of both sexes
3. Age since birth till three years
4. Type of feeding : diet restriction of phenylalanine
5. Controls: normal healthy children match with cases in the same social class, age and sex
Exclusion Criteria:
1. Age greater than three years
2. Patients diagnosed with PKU and not regular in feeding for special diet and formula.
3. PKU patients not diagnosed since birth
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
3 Years
Study:
NCT04302194
Study Brief:
Protocol Section:
NCT04302194