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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561340
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : February 9, 2015
Last Update Posted : February 9, 2015
Information provided by (Responsible Party):
Christopher J. Kratochvil, M.D., University of Nebraska

November 16, 2007
November 20, 2007
December 29, 2014
February 9, 2015
February 9, 2015
January 2006
September 2010   (Final data collection date for primary outcome measure)
  • Weight Change [ Time Frame: 6 months ]
    Change in weight observed from baseline to 6 months
  • Height Change [ Time Frame: 6 months ]
    Change in height from baseline to 6 months
  • 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 ]
Complete list of historical versions of study NCT00561340 on Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
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
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Dietary Supplement: Pediasure
    50% will be randomized to pediasure with nutritional counseling
  • Behavioral: Nutritional counseling
    50% randomized to nutritional counseling only
  • Experimental: 1 Can of Pediasure Supplement Plus Nutritional Counseling
    Pediasure and nutritional counseling
    • Dietary Supplement: Pediasure
    • Behavioral: Nutritional counseling
  • Active Comparator: Counseling by the Provider on Ways to Encourage Caloric Intake
    Behavioral intervention - Nutritional Counseling
    Intervention: Behavioral: Nutritional counseling
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2010
September 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 9 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
B4Z-US-X018 ( Other Identifier: Eli Lilly and Company )
11112 ( Other Identifier: Abbott Laboratories )
Not Provided
Not Provided
Christopher J. Kratochvil, M.D., University of Nebraska
University of Nebraska
Not Provided
Principal Investigator: Christopher J Kratochvil, MD University of Nebraska
University of Nebraska
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP