Overview

This trial is active, not recruiting.

Condition adhd
Treatments pediasure, nutritional counseling
Phase phase 4
Sponsor University of Nebraska
Start date January 2006
End date July 2010
Trial size 60 participants
Trial identifier NCT00561340, 11112, 356-05-FB, B4Z-US-X018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Pediasure and nutritional counseling
pediasure
50% will be randomized to pediasure with nutritional counseling
(Active Comparator)
Behavioral intervention - Nutritional Counseling
nutritional counseling
50% randomized to nutritional counseling only

Primary Outcomes

Measure
Weight Percentile
time frame: 2 years
Height Percentile
time frame: 2 years
BMI Percentile
time frame: 2 years
ADHD-IV Rating Scale Total Score
time frame: 2 years

Secondary Outcomes

Measure
Conners' Parent Rating Scale
time frame: 2 years
Clinical Global Impression-Severity (CGI-S)
time frame: 2 years
Clinical Global Impression-Improvement(CGI-I)
time frame: 2 years
Children's Global Assessment Scale (CGAS)
time frame: 2 years

Eligibility Criteria

Male or female participants from 5 years up to 9 years old.

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.

Additional Information

Official title Caloric Supplementation During Long-Term Pharmacological Treatment of ADHD in Young Children
Principal investigator Christopher J Kratochvil, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by University of Nebraska.