Effect of Nutritional Formula Supplementation on Growth of Prepubertal Children Treated With Stimulants Medications for Attention Deficit Hyperactivity Disorder (ADHD)
NCT ID: NCT04962334
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
70 participants
INTERVENTIONAL
2021-07-01
2024-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
70 Participants treated with stimulants medications of ADHD will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. Randomization will be stratified according to gender.
Participants in the intervention groups will be treated with the study formula and participants in the control group will be treated with a placebo low caloric formula (Powder added to water). The study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.
In addition, 30 prepubertal healthy siblings will be recruited to the study in order to compare baseline eating and physical activity patterns of ADHD children treated with stimulants to their healthy untreated siblings at the same age range. Participants' siblings will only complete once the nutritional and physical activity questionnaire and report height and weight measurements.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With ADHD
NCT00712699
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
NCT01109849
Attention-Deficit/Hyperactivity Disorder (ADHD) Brain Activity Changes to Psychostimulants
NCT01310439
The Effects of a Single Dose of Methylphenidate on Motor Performance
NCT04283604
Stimulant Drug Treatment of Attention-Deficit Hyperactivity Disorder (AD/HD), Inattentive Type
NCT00824317
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nutritional Standardized Supplementation Formula
Powder added to water, containing about 25% of recommended daily recommended intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake
Nutritional supplementation standardized formula.
Powder added to water, containing about 25% of recommended daily recommended intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake
Placebo
Low caloric formula (Powder added to waster) without added vitamins and minerals
Placebo
Low caloric formula (powder added to water) without added vitamins and minerals
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nutritional supplementation standardized formula.
Powder added to water, containing about 25% of recommended daily recommended intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake
Placebo
Low caloric formula (powder added to water) without added vitamins and minerals
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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).
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NG Solutions Ltd
UNKNOWN
Rabin Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Moshe Phillip, Prof
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Schneider children's medical center
Petah Tikva, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
rmc013521ctil
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.