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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-US-X018 | Other Identifier | Eli Lilly and Company | |
| 11112 | Other Identifier | Abbott Laboratories |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Can of Pediasure Supplement Plus Nutritional Counseling | Experimental | Pediasure and nutritional counseling |
|
| Counseling by the Provider on Ways to Encourage Caloric Intake | Active Comparator | Behavioral intervention - Nutritional Counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediasure | Dietary Supplement | 50% will be randomized to pediasure with nutritional counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Change in weight observed from baseline to 6 months | 6 months |
| Height Change | Change in height from baseline to 6 months | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Kratochvil, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center, Department of Psychiatry | Omaha | Nebraska | 68105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15995021 | Background | 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. |
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25 subjects were randomized to one of the 2 treatment groups. An additional 4 subjects for whom randomization to caloric supplementation was inappropriate were included in the nutritional counseling only arm for purposes of analysis as they did enroll in this study.
33 subjects total were eligible for participation in this study. 29 were enrolled and are included in the analysis. All patients had previously completed an 8-week double-blind placebo-controlled study of atomoxetine for the treatment of ADHD in 5 and 6 year olds.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Can of Pediasure Supplement Plus Nutritional Counseling | Pediasure and nutritional counseling Pediasure: 50% will be randomized to pediasure with nutritional counseling |
| FG001 | Counseling by the Provider on Ways to Encourage Caloric Intake | Behavioral intervention - Nutritional Counseling Nutritional counseling: 50% randomized to nutritional counseling only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 25 subjects were eligible for randomization. 4 subjects were not appropriate for randomization to caloric supplementation with pediasure so were included in the counseling only arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Can of Pediasure Supplement Plus Nutritional Counseling | Pediasure and nutritional counseling Pediasure: 50% will be randomized to pediasure with nutritional counseling |
| BG001 | Counseling by the Provider on Ways to Encourage Caloric Intake |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Change | Change in weight observed from baseline to 6 months | 29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure. | Posted | Mean | Standard Deviation | kilograms | 6 months |
|
Study duration was 2 years. Intervention (pediasure) was only during first 6 months of the study.
Adverse events solicited through open-ended questioning of the parent and subject by the investigator
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Can of Pediasure Supplement Plus Nutritional Counseling | Pediasure and nutritional counseling Pediasure: 50% will be randomized to pediasure with nutritional counseling |
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This is a follow-up study of 5 and 6 year olds who completed a DBPC study of atomoxetine for ADHD. Data is confounded by subjects having entered the study on different pre-study and concurrent pharmacotherapy. The population is small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kratochvil | University of Nebraska Medical Center | 402-552-6005 | ckratoch@unmc.edu |
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| 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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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Nutritional counseling | Behavioral | 50% randomized to nutritional counseling only |
|
Behavioral intervention - Nutritional Counseling Nutritional counseling: 50% randomized to nutritional counseling only |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ADHD treatment status | Number | participants |
|
Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only
|
|
| Primary | Height Change | Change in height from baseline to 6 months | 29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure. | Posted | Mean | Standard Deviation | centimeters | 6 months |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Counseling by the Provider on Ways to Encourage Caloric Intake | Behavioral intervention - Nutritional Counseling Nutritional counseling: 50% randomized to nutritional counseling only | 0 | 16 | 0 | 16 | 0 | 16 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |