ClinicalTrials.gg
RecruitingNCT04962334Updated Mar 26, 2024

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

An interventional study of Nutritional supplementation standardized formula. and Placebo in ADHD - Attention Deficit Disorder With Hyperactivity, sponsored by Rabin Medical Center. Recruiting at 1 site in Israel. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
Up to 10 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 85 studies in Attention Deficit Disorder with Hyperactivity with a site in Israel — 9 open to participants now, 10 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · Israel.

Planned enrollment
20th of 61
70 · median 46
Started
2021
with 3 others
No phase
38 of 85
6 open now
Registered
66th of 85
by date
Lead sponsor
3 of 85
Rabin Medical Center

Among the 85 studies in Attention Deficit Disorder with Hyperactivity with a site in Israel, this one is the 20th largest by planned enrollment of the 61 interventional ones that give a count, is one of 4 that started in 2021, is one of 38 with no phase, and was the 66th registered.

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

Browse Attention Deficit Disorder with Hyperactivity studies →

Open to participants now

9 of the 85 studies in Attention Deficit Disorder with Hyperactivity with a site in Israel are open now. Recruiting first, the newest first:

3 more — sign in →

All 9 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.

This study: Up to 10 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • ADHD - Attention Deficit Disorder With Hyperactivity
04

Who can participate

Ages eligible
Up to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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: -SDS ≤ 85th percentile for age and gender according to the CDC 2000 growth charts
  5. Signing inform consent forms

Exclusion criteria

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 , 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • 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.

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementNutritional 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

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. height standard deviation score (SDS)

    Time frame: at 6 months

  2. weight standard deviation score

    Time frame: at 6 months

Secondary outcomes

  1. BMI SDS

    Time frame: at 6 months

  2. Fat Mass

    Time frame: at 6 months

  3. Lean body mass

    Time frame: at 6 months

  4. Muscle mass

    Time frame: at 6 months

  5. Change in dietary patterns measured by Child Eating Behaviour Questionnaire

    Time frame: At 6 months

  6. Change in ADHD symptoms measured by Vanderblit ADHD Parent Rating Scale

    Time frame: at 6 months

  7. Change in physical activity patterns measured by physical activity questionnaire

    Time frame: at 6 months

Other outcomes

  1. height SDS

    Time frame: at 12 months

  2. Weight SDS

    Time frame: at 12 months

  3. BMI SDS

    Time frame: at 12 months

  4. Fat mass

    Time frame: at 12 months

  5. Lean body mass

    Time frame: at 12 months

  6. Muscle mass

    Time frame: at 12 months

  7. Change in dietary patterns measured by Child Eating Behaviour Questionnaire

    Time frame: at 12 months

  8. Change in ADHD symptoms measured by Vanderblit ADHD Parent Rating Scale

    Time frame: at 12 months

  9. Change in physical activity measured by physical activity questionnaire

    Time frame: at 12 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Jul 2024, 36 months after the start.

Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 36 months is above that.

Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2021
First posted
Jul 14, 2021
StartActual
Jul 1, 2021
Primary completionEst.
Jul 2024
CompletionEst.
Jul 2024
Last update
Mar 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04962334
Collaborators
NG Solutions Ltd
Responsible party
Sponsor
First posted
Jul 14, 2021
Start date
Jul 1, 2021
Primary completion
Jul 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Mar 26, 2024

Study contacts

Moshe Phillip, Prof
Contact
mosheph@clalit.org.il
972-3-9253282
Alona Hamou, Msc
Contact
alonah@clalit.org.il
972-3-9253747
Moshe Phillip, Prof
principal investigator · Schneider Children's Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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