Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication

Not Applicable

Completed

• Conditions: ADHD
• Interventions: Behavioral: Nutritional counseling; Dietary Supplement: Pediasure

• Registration Number: NCT00561340
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study Start: 2006-01-02
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2010-09-01
• Study Completion: 2010-09-01
• Results First Submitted: 2014-12-29
• Results First Submitted QC: 2015-01-25
• Results First Posted: 2015-02-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counseling by the Provider on Ways to Encourage Caloric Intake	Nutritional counseling	Behavioral intervention - Nutritional Counseling
1 Can of Pediasure Supplement Plus Nutritional Counseling	Nutritional counseling	Pediasure and nutritional counseling
1 Can of Pediasure Supplement Plus Nutritional Counseling	Pediasure	Pediasure and nutritional counseling

Primary Outcome Measures

Name	Time	Method
Weight Change	6 months	Change in weight observed from baseline to 6 months
Height Change	6 months	Change in height from baseline to 6 months

Trial Locations

Locations (1)

University of Nebraska Medical Center, Department of Psychiatry; 🇺🇸 Omaha, Nebraska, United States