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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT04962334
Eligibility Criteria:
Inclusion Criteria:
1. Boys aged ≤ 10 years and girls aged ≤ 9 years.
2. Children treated with stimulants medications for ADHD for at list 3 months.
3. Prepubertal -Tanner stage 1 (gonadarche) (boys: testicular volume \< 4, girls: breast at Tanner stage 1)
4. Normal weight status: BMI-SDS ≤ 85th percentile for age and gender according to the CDC 2000 growth charts
5. Signing inform consent forms
Exclusion Criteria:
1. Diagnosis of GH Deficiency or treatment with GH
2. Any known chronic disease or dysmorphic syndrome including bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems
3. Any known gastrointestinal disease including malabsorption
4. Any known organic reason for growth retardation
5. Milk allergy.
6. Any chronic treatment with additional medication beside stimulants that might affect appetite, weight, or growth (for example SSRI's).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
10 Years
Study:
NCT04962334
Study Brief:
Protocol Section:
NCT04962334