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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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ADHD

Intervention / Treatment
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* Dietary Supplement: Pediasure
* Behavioral: Nutritional counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Can of Pediasure Supplement Plus Nutritional Counseling<br>Pediasure and nutritional counseling | Dietary Supplement: Pediasure<br>* 50% will be randomized to pediasure with nutritional counseling<br>Behavioral: Nutritional counseling<br>* 50% randomized to nutritional counseling only<br>|
| Active Comparator: Counseling by the Provider on Ways to Encourage Caloric Intake<br>Behavioral intervention - Nutritional Counseling | Behavioral: Nutritional counseling<br>* 50% randomized to nutritional counseling only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | Change in weight observed from baseline to 6 months | 6 months | 
| Height Change | Change in height from baseline to 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Growth, Atomoxetine, Pediasure