Effect of Nutritional Formula Supplementation on Growth of Prepubertal Children Treated With Stimulants Medications for Attention Deficit Hyperactivity Disorder (ADHD)

Effect of Nutritional Formula Supplementation on Growth of Prepubertal Children Treated With Stimulants Medications for ADHD. A Randomized Double-blind, Placebo-controlled Trial

The proposed study is a double blind, randomized, placebo controlled study. The aim of the study is to evaluate the effect of nutritional formula supplementation on growth of prepubertal children treated with stimulants medications of ADHD.

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD - Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Dietary supplement: Nutritional supplementation standardized formula.; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alona Hamou, Msc; Phone Number: 972-3-9253747; Email: alonah@clalit.org.il
• Study Contact Backup: Name: Moshe Phillip, Prof; Phone Number: 972-3-9253282; Email: mosheph@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Schneider Children's Medical Center
    • Contact: Moshe Phillip, Prof; Phone Number: 972-39253282; Email: mosheph@clalit.org.il
    • Sub-Investigator: Liora Lazar, Prof.
    • Sub-Investigator: Naama Fish, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 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 Comparator: Placebo; Low caloric formula (Powder added to waster) without added vitamins and minerals	Dietary supplement: Placebo; Low caloric formula (powder added to water) without added vitamins and minerals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
height standard deviation score (SDS)	at 6 months
weight standard deviation score	at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
BMI SDS	at 6 months
Fat Mass	at 6 months
Lean body mass	at 6 months
Muscle mass	at 6 months
Change in dietary patterns measured by Child Eating Behaviour Questionnaire	At 6 months
Change in ADHD symptoms measured by Vanderblit ADHD Parent Rating Scale	at 6 months
Change in physical activity patterns measured by physical activity questionnaire	at 6 months

Other Outcome Measures

Outcome Measure	Time Frame
Weight SDS	at 12 months
BMI SDS	at 12 months
height SDS	at 12 months
Fat mass	at 12 months
Lean body mass	at 12 months
Muscle mass	at 12 months
Change in dietary patterns measured by Child Eating Behaviour Questionnaire	at 12 months
Change in ADHD symptoms measured by Vanderblit ADHD Parent Rating Scale	at 12 months
Change in physical activity measured by physical activity questionnaire	at 12 months

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: NG Solutions Ltd
• Investigators: Principal Investigator: Moshe Phillip, Prof, Schneider Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: rmc013521ctil

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No