Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication - Full Text View

Purpose

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.

Condition	Intervention	Phase
ADHD	Dietary Supplement: Pediasure Behavioral: Nutritional counseling	Phase IV

ChemIDplus related topics:

Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Weight Percentile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Height Percentile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
BMI Percentile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
ADHD-IV Rating Scale Total Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Conners' Parent Rating Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Clinical Global Impression-Severity (CGI-S) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Clinical Global Impression-Improvement(CGI-I) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Children's Global Assessment Scale (CGAS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2006
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pediasure and nutritional counseling	Dietary Supplement: Pediasure 50% will be randomized to pediasure with nutritional counseling
2: Active Comparator Behavioral intervention - Nutritional Counseling	Behavioral: Nutritional counseling 50% randomized to nutritional counseling only

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.

Eligibility

Ages Eligible for Study:	5 Years to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561340

Contacts


Contact: Brigette S Vaughan, APRN	402-552-6239	bvaughan@unmc.edu

Locations


United States, Nebraska
	University of Nebraska Medical Center, Department of Psychiatry	Recruiting
	Omaha, Nebraska, United States, 68105
	Principal Investigator: Christopher J Kratochvil, MD

Sponsors and Collaborators

University of Nebraska

Investigators


Principal Investigator:	Christopher J Kratochvil, MD	University of Nebraska

More Information

Publications:

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.

Responsible Party:	University of Nebraska Medical Center ( Christopher J. Kratochvil, M.D. )
Study ID Numbers:	IRB# 356-05, B4Z-US-X018, 11112
First Received:	November 16, 2007
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00561340
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:

ADHD

Growth

Atomoxetine

Pediasure

Study placed in the following topic categories:

Atomoxetine

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00561340