NCT00561340

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

Caloric Supplementation During Long-Term Pharmacological Treatment of ADHD in Young Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ADHD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pediasure	50% will be randomized to pediasure with nutritional counseling
BEHAVIORAL	Nutritional counseling	50% randomized to nutritional counseling only

Timeline

• Start date: 2006-01-02
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-11-20
• Last updated: 2023-10-04
• Results posted: 2015-02-09

Locations

1 site across 1 country: United States