Nutritional formula's effect on growth in children with ADHD on stimulant medications
Effect of Nutritional Formula Supplementation on Growth of Prepubertal Children Treated With Stimulants Medications for ADHD. A Randomized Double-blind, Placebo-controlled Trial
This study is testing if a special nutritional formula can help children with ADHD who are on medication grow better over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 10 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petach Tikva) |
| Trial ID | NCT04962334 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a nutritional formula supplementation on the growth of prepubertal children who have been treated with stimulant medications for ADHD. It is a double-blind, randomized, placebo-controlled trial involving 70 participants, who will be assigned to either the intervention group receiving the nutritional formula or a placebo group. The study will last for 6 months, with an additional 6-month extension period for both groups. Randomization will be stratified by gender to ensure balanced representation.
Who should consider this trial
Good fit: Ideal candidates are boys aged 10 years or younger and girls aged 9 years or younger who have been on stimulant medications for ADHD for at least 3 months.
Not a fit: Patients with growth hormone deficiency, chronic diseases, or gastrointestinal issues that affect growth may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve growth outcomes in children with ADHD who are on stimulant medications.
How similar studies have performed: While similar studies have explored nutritional interventions, this specific approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Petach Tikva
- Schneider children's medical center — Petach Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Moshe Phillip, Prof — Schneider Children's Medical Center
- Study coordinator: Moshe Phillip, Prof
- Email: mosheph@clalit.org.il
- Phone: 972-3-9253282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.