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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Nebraska.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00561340
First received: November 16, 2007
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: 1
Pediasure and nutritional counseling
 Dietary Supplement: Pediasure
50% will be randomized to pediasure with nutritional counseling
Active Comparator: 2
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

Locations
United States, Nebraska
University of Nebraska Medical Center, Department of Psychiatry
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Christopher J Kratochvil, MD University of Nebraska
  More Information

Publications:

Responsible Party: Christopher J. Kratochvil, M.D., University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00561340     History of Changes
Other Study ID Numbers: 356-05-FB, B4Z-US-X018, 11112
Study First Received: November 16, 2007
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
ADHD
Growth
Atomoxetine
Pediasure

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013