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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03333720
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* 8 years of age and older
* Diagnosed with proven PKU
* Consume a minimum of 20g protein equivalent in tablet format while enrolled on to the trial
* If routine care and dietary management is not different from normal PKU care and dietary management, preconception patients may be considered
* Have written informed consent from patient or parent/carer carer
Exclusion Criteria:
* Requiring nutritional support (including enteral and parenteral nutrition)
* Major hepatic or renal dysfunction
* Maternal PKU patients (if a patient becomes pregnant during the study they will be withdrawn on immediate notice to the Metabolic Dietitian responsible for the patient's care)
* Participation in other studies within 1 month prior to entry of this study
* Investigator concern around willingness/ability of patient to comply with protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
100 Years
Study:
NCT03333720
Study Brief:
Protocol Section:
NCT03333720