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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT04284059
Eligibility Criteria:
Inclusion Criteria:
* Diagnose of ADHD according to DSM-5
* Aged 6-12 years
* Intelligence quotient (IQ) ≥70
* Receiving methylphenidate (trade name Concerta) 18-54 mg/day once a day (began with 18 mg/day for a week and titrated gradually to the optimum dose not more than 54 mg/day).
Exclusion Criteria:
* Inconsistent or changing dose of methylphenidate during the participation period
* Use of anticonvulsant drugs or hydrocortisone
* Suffering from other neurological disorders and mental diseases now or in the past, such as convulsions, anxiety and depression
* Suffer from metabolic disorders such as cholestasis, liver dysfunction, pancreatic insufficiency, measles, diarrhea, respiratory illness, severe inflammation or malnutrition, etc.
* Use of vitamins and vitamin-containing products
* IQ≤70
* The serum concentration of vitamin A \>1.05 umol/L and/ or vitamin D \>50 nmol/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT04284059
Study Brief:
Protocol Section:
NCT04284059