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

University of Nebraska

Status: Completed

Conditions: ADHD

Treatments: Dietary Supplement: Pediasure; Behavioral: Nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00561340

B4Z-US-X018 (Other Identifier)

0356-05-FB

11112 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

1 Can of Pediasure Supplement Plus Nutritional Counseling

Experimental group

Description:

Pediasure and nutritional counseling

Treatment:

Dietary Supplement: Pediasure

Behavioral: Nutritional counseling

Counseling by the Provider on Ways to Encourage Caloric Intake

Active Comparator group

Description:

Behavioral intervention - Nutritional Counseling

Treatment:

Behavioral: Nutritional counseling