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

NCT04962334 | Recruiting

• 1 other identifier: rmc013521ctil
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (2)

• height standard deviation score (SDS)

  at 6 months

• weight standard deviation score

  at 6 months

Secondary Outcomes (7)

• 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

Other Outcomes (9)

• height SDS

  at 12 months

• Weight SDS

  at 12 months

• BMI SDS

  at 12 months

Study Arms (2)

Nutritional Standardized Supplementation Formula

EXPERIMENTAL

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.

Placebo

PLACEBO COMPARATOR

Low caloric formula (Powder added to waster) without added vitamins and minerals

Dietary Supplement: Placebo

Interventions

Nutritional supplementation standardized formula. DIETARY_SUPPLEMENT

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 Standardized Supplementation Formula

Placebo DIETARY_SUPPLEMENT

Low caloric formula (powder added to water) without added vitamins and minerals

Placebo

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys aged ≤ 10 years and girls aged ≤ 9 years.
• Children treated with stimulants medications for ADHD for at list 3 months.
• Prepubertal -Tanner stage 1 (gonadarche) (boys: testicular volume \< 4, girls: breast at Tanner stage 1)
• Normal weight status: BMI-SDS ≤ 85th percentile for age and gender according to the CDC 2000 growth charts
• Signing inform consent forms

You may not qualify if:

• Diagnosis of GH Deficiency or treatment with GH
• 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
• Any known gastrointestinal disease including malabsorption
• Any known organic reason for growth retardation
• Milk allergy.
• Any chronic treatment with additional medication beside stimulants that might affect appetite, weight, or growth (for example SSRI's).

Sponsors & Collaborators

• Rabin Medical Center: lead
• NG Solutions Ltd: collaborator

Study Sites (1)

Schneider children's medical center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Moshe Phillip, Prof

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Phillip, Prof

CONTACT

972-3-9253282; mosheph@clalit.org.il

Alona Hamou, Msc

CONTACT

972-3-9253747; alonah@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 14, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

IL (1)