ADHD - Attention Deficit Disorder With HyperactivityNCT04962334
Effect of Nutritional Formula Supplementation on Growth of Prepubertal Children Treated With Stimulants Medications for Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Nutritional supplementation standardized formula. in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Nutritional supplementation standardized formula.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider children's medical center
Petah Tikva
Moshe Phillip, Prof, 972-39253282, mosheph@clalit.org.il
Naama Fish, Dr.
About this study
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
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.
Read more
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.
- Being tested
- Nutritional supplementation standardized formula., Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDietary supplement
Low caloric formula (powder added to water) without added vitamins and minerals
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Nutritional supplementation standardized formula. |
| Placebo | Placebo comparator | Low caloric formula (Powder added to waster) without added vitamins and minerals Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
height standard deviation score (SDS)
Measured: at 6 months
weight standard deviation score
Measured: at 6 months
Secondary outcomes (7)
BMI SDS
Measured: at 6 months
Fat Mass
Measured: at 6 months
Lean body mass
Measured: at 6 months
Muscle mass
Measured: at 6 months
Change in dietary patterns measured by Child Eating Behaviour Questionnaire
Measured: At 6 months
Change in ADHD symptoms measured by Vanderblit ADHD Parent Rating Scale
Measured: at 6 months
Change in physical activity patterns measured by physical activity questionnaire
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Jul 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NG Solutions Ltd
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962334
- Sponsor's protocol ID
- rmc013521ctil
- Status last verified
- Mar 2024
- First submitted
- 29 Jun 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04962334
- Acronym / sponsor ID
- rmc013521ctil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- NG Solutions Ltd
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Standardized Supplementation Formula | Experimental | Dietary Supplement: Nutritional 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboLow caloric formula (Powder added to waster) without added vitamins and minerals |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional 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 supplement | Nutritional Standardized Supplementation Formula |
| PlaceboLow caloric formula (powder added to water) without added vitamins and minerals | Dietary supplement | Placebo |
Primary outcome
height standard deviation score (SDS)
Time frame: at 6 months
weight standard deviation score
Time frame: at 6 months
7 secondary outcomes
BMI SDS
Time frame: at 6 months
Fat Mass
Time frame: at 6 months
Lean body mass
Time frame: at 6 months
Muscle mass
Time frame: at 6 months
Change in dietary patterns measured by Child Eating Behaviour Questionnaire
Time frame: At 6 months
Change in ADHD symptoms measured by Vanderblit ADHD Parent Rating Scale
Time frame: at 6 months
Change in physical activity patterns measured by physical activity questionnaire
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Phillip, Prof principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplementation standardized formula. in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshe Phillip, Prof (972-3-9253282, mosheph@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
height standard deviation score (SDS) (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.