ADHDNCT00561340
Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication
A study testing Pediasure and Nutritional counseling in people with ADHD, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to see if supplementing calories with Pediasure is effective in maintaining height, weight, and BMI percentiles for young children during 2 years of treatment with ADHD medication. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- ADHD
- What is being tested?
- Pediasure and Nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2006to 1 Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who participated in the 8 week DBPC trial of atomoxetine (1K23MH066127) who wish to participate in a long-term, open label trial of atomoxetine.
- Parents and patients must be able to attend regular study visits. Visits will be scheduled every 30 days for the first 6 months and then every 60 days for the next 18 months.
- Children who are on alternate medications due to inefficacy or intolerability of atomoxetine may still participate.
Who cannot join
- Parents who are unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Department of Psychiatry
Omaha, Nebraska, 68105
About this study
Official title: Caloric Supplementation During Long-Term Pharmacological Treatment of ADHD in Young Children
The purpose of this study is to see if supplementing calories with Pediasure is effective in maintaining height, weight, and BMI percentiles for young children during 2 years of treatment with ADHD medication.
Read the detailed description
This is a pilot study evaluating the effect of caloric supplementation on maintenance of growth parameters during two years of open-label atomoxetine treatment in 5 and 6 year old children with ADHD. The study will assess the efficacy of caloric supplementation in maintaining baseline percentiles for height, weight, and body mass index (BMI). Patients will be randomly assigned to receive either PediaSure for caloric supplementation, or no supplementation.
Secondary aims include assessing the tolerability and efficacy of long-term, open-label atomoxetine treatment in 5 and 6 year old children with ADHD, and obtaining adequate pilot data regarding the safety, efficacy, and potential effects of atomoxetine on growth parameters in order to submit a multisite R01 to more adequately assess atomoxetine treatment and its effects in young children with ADHD.
- Conditions
- ADHD
- Being tested
- Pediasure, Nutritional counseling
- Keywords
- ADHD, Growth, Atomoxetine, Pediasure
- 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.
PediasureDietary supplement
50% will be randomized to pediasure with nutritional counseling
Nutritional counselingBehavioural
50% randomized to nutritional counseling only
| Study group | Role | What they receive |
|---|---|---|
| 1 Can of Pediasure Supplement Plus Nutritional Counseling | Experimental | Pediasure and nutritional counseling Receives: Dietary Supplement: Pediasure; Behavioral: Nutritional counseling |
| Counseling by the Provider on Ways to Encourage Caloric Intake | Active comparator | Behavioral intervention - Nutritional Counseling Receives: Behavioral: Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Change in weight observed from baseline to 6 months
Measured: 6 months
Height Change
Change in height from baseline to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study start2 Jan 2006
- Primary completion1 Sep 2010
- Study completion1 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher J Kratochvil, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561340
- Sponsor's protocol ID
- 0356-05-FB
- Other IDs
- B4Z-US-X018, 11112
- Status last verified
- Sep 2023
- First submitted
- 16 Nov 2007
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Spencer TJ, Newcorn JH, Kratochvil CJ, Ruff D, Michelson D, Biederman J. Effects of atomoxetine on growth after 2-year treatment among pediatric patients with attention-deficit/hyperactivity disorder. Pediatrics. 2005 Jul;116(1):e74-80. doi: 10.1542/peds.2004-0624.
PubMed 15995021
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Supplementation During Long-Term Pharmacological Treatment of ADHD in Young Children
- ClinicalTrials.gov ID
- NCT00561340
- Acronym / sponsor ID
- 0356-05-FB
- Conditions
- ADHD
- Keywords
- ADHD, Growth, Atomoxetine, Pediasure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 2 Jan 2006 (actual)
- Primary completion
- 1 Sep 2010 (actual)
- Study completion
- 1 Sep 2010 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Posted 9 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if supplementing calories with Pediasure is effective in maintaining height, weight, and BMI percentiles for young children during 2 years of treatment with ADHD medication.
Detailed description
This is a pilot study evaluating the effect of caloric supplementation on maintenance of growth parameters during two years of open-label atomoxetine treatment in 5 and 6 year old children with ADHD. The study will assess the efficacy of caloric supplementation in maintaining baseline percentiles for height, weight, and body mass index (BMI). Patients will be randomly assigned to receive either PediaSure for caloric supplementation, or no supplementation.
Secondary aims include assessing the tolerability and efficacy of long-term, open-label atomoxetine treatment in 5 and 6 year old children with ADHD, and obtaining adequate pilot data regarding the safety, efficacy, and potential effects of atomoxetine on growth parameters in order to submit a multisite R01 to more adequately assess atomoxetine treatment and its effects in young children with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Can of Pediasure Supplement Plus Nutritional Counseling | Experimental | Dietary Supplement: Pediasure, Behavioral: Nutritional counselingPediasure and nutritional counseling |
| Counseling by the Provider on Ways to Encourage Caloric Intake | Active comparator | Behavioral: Nutritional counselingBehavioral intervention - Nutritional Counseling |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children who participated in the 8 week DBPC trial of atomoxetine (1K23MH066127) who wish to participate in a long-term, open label trial of atomoxetine.
- Parents and patients must be able to attend regular study visits. Visits will be scheduled every 30 days for the first 6 months and then every 60 days for the next 18 months.
- Children who are on alternate medications due to inefficacy or intolerability of atomoxetine may still participate.
Key exclusion criteria (1 listed)
- Parents who are unwilling to provide informed consent.
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 |
|---|---|---|
| Pediasure50% will be randomized to pediasure with nutritional counseling | Dietary supplement | 1 Can of Pediasure Supplement Plus Nutritional Counseling |
| Nutritional counseling50% randomized to nutritional counseling only | Behavioural | 1 Can of Pediasure Supplement Plus Nutritional Counseling, Counseling by the Provider on Ways to Encourage Caloric Intake |
Primary outcome
Weight Change
Time frame: 6 months
Change in weight observed from baseline to 6 months
Height Change
Time frame: 6 months
Change in height from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15995021Spencer TJ, Newcorn JH, Kratochvil CJ, Ruff D, Michelson D, Biederman J. Effects of atomoxetine on growth after 2-year treatment among pediatric patients with attention-deficit/hyperactivity disorder. Pediatrics. 2005 Jul;116(1):e74-80. doi: 10.1542/peds.2004-0624.
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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.
Christopher J Kratochvil, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediasure and Nutritional counseling in people with ADHD, run by University of Nebraska at 1 site in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 4 Oct 2023. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: 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?
On the ClinicalTrials.gov record for NCT00561340, which also lists 1 linked publication.
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 4 Oct 2023.