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| Name | Class |
|---|---|
| NG Solutions Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Low caloric formula (Powder added to waster) without added vitamins and minerals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| height standard deviation score (SDS) | at 6 months | |
| weight standard deviation score | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI SDS | at 6 months | |
| Fat Mass | at 6 months | |
| Lean body mass |
| Measure | Description | Time Frame |
|---|---|---|
| height SDS | at 12 months | |
| Weight SDS | at 12 months | |
| BMI SDS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moshe Phillip, Prof | Contact | 972-3-9253282 | mosheph@clalit.org.il | |
| Alona Hamou, Msc | Contact | 972-3-9253747 | alonah@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Schneider Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider children's medical center | Recruiting | Petah Tikva | Israel |
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|
| Placebo | Dietary Supplement | Low caloric formula (powder added to water) without added vitamins and minerals |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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