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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 10
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Israel
Schneider children's medical center
RECRUITING
Petah Tikva
Contact Information
Primary
Moshe Phillip, Prof
mosheph@clalit.org.il
972-3-9253282
Backup
Alona Hamou, Msc
alonah@clalit.org.il
972-3-9253747
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2024-07
Participants
Target number of participants: 70
Treatments
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
Placebo_comparator: Placebo
Low caloric formula (Powder added to waster) without added vitamins and minerals
Sponsors
Collaborators: NG Solutions Ltd
Leads: Rabin Medical Center

This content was sourced from clinicaltrials.gov

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