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Completed

NCT Number: NCT00561340

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center, Department of Psychiatry

Omaha, Nebraska, 68105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pediasure

Dietary Supplement

50% will be randomized to pediasure with nutritional counseling

Nutritional counseling

Behavioral

50% randomized to nutritional counseling only

Primary outcomes

  1. Weight Change

    Time frame: 6 months

    Change in weight observed from baseline to 6 months

  2. Height Change

    Time frame: 6 months

    Change in height from baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 20, 2007
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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