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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07424495
Eligibility Criteria:
Inclusion Criteria:
* Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar (HCB).
* Written informed consent provided by the legal guardian through the signing of the Informed Consent Form (ICF).
* Assent from the child or adolescent, when applicable, expressed through the signing of the Informed Assent Form (IAF).
Exclusion Criteria:
* Children or adolescents with dietary restrictions or known allergies to any component present in the formulations used in the study.
* Children or adolescents with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* Children or adolescents diagnosed with severe neurological, cognitive, or behavioral disorders that impair communication, comprehension, or response to the sensory scale.
* Oral conditions, mucosal lesions, or dysphagia that prevent or significantly impair proper chewing or swallowing of the tablet (e.g., mucositis).
* Refusal of the child/adolescent or legal guardian to participate in the study at any time, even after prior consent has been provided.
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT07424495
Study Brief:
Protocol Section:
NCT07424495