Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT04962334
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2021-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nutritional Formula Supplementation on Growth of Prepubertal Children Treated With Stimulants Medications for Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: