Back to resultsStudy of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pediasure
Nutritional counseling
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, Growth, Atomoxetine, Pediasure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Parents who are unwilling to provide informed consent.
Sites / Locations
- University of Nebraska Medical Center, Department of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 Can of Pediasure Supplement Plus Nutritional Counseling
Counseling by the Provider on Ways to Encourage Caloric Intake
Arm Description
Pediasure and nutritional counseling
Behavioral intervention - Nutritional Counseling
Outcomes
Primary Outcome Measures
Weight Change
Change in weight observed from baseline to 6 months
Height Change
Change in height from baseline to 6 months
Secondary Outcome Measures
Full Information
NCT ID
NCT00561340
First Posted
November 16, 2007
Last Updated
September 27, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT00561340
Brief Title
Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication
Official Title
Caloric Supplementation During Long-Term Pharmacological Treatment of ADHD in Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2006 (Actual)
Primary Completion Date
September 1, 2010 (Actual)
Study Completion Date
September 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Growth, Atomoxetine, Pediasure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Can of Pediasure Supplement Plus Nutritional Counseling
Arm Type
Experimental
Arm Description
Pediasure and nutritional counseling
Arm Title
Counseling by the Provider on Ways to Encourage Caloric Intake
Arm Type
Active Comparator
Arm Description
Behavioral intervention - Nutritional Counseling
Intervention Type
Dietary Supplement
Intervention Name(s)
Pediasure
Intervention Description
50% will be randomized to pediasure with nutritional counseling
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counseling
Intervention Description
50% randomized to nutritional counseling only
Primary Outcome Measure Information:
Title
Weight Change
Description
Change in weight observed from baseline to 6 months
Time Frame
6 months
Title
Height Change
Description
Change in height from baseline to 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Parents who are unwilling to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Kratochvil, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, Department of Psychiatry
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15995021
Citation
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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Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication
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