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

NCT ID: NCT00561340

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-02
• Study Completion Date: 2010-09-01

Brief Summary

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

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 Can of Pediasure Supplement Plus Nutritional Counseling

Pediasure and nutritional counseling

Group Type: EXPERIMENTAL

Pediasure

Intervention Type: DIETARY_SUPPLEMENT

50% will be randomized to pediasure with nutritional counseling

Nutritional counseling

Intervention Type: BEHAVIORAL

50% randomized to nutritional counseling only

Counseling by the Provider on Ways to Encourage Caloric Intake

Behavioral intervention - Nutritional Counseling

Group Type: ACTIVE_COMPARATOR

Nutritional counseling

Intervention Type: BEHAVIORAL

50% randomized to nutritional counseling only

Interventions

Pediasure

50% will be randomized to pediasure with nutritional counseling

Intervention Type: DIETARY_SUPPLEMENT

Nutritional counseling

50% randomized to nutritional counseling only

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J Kratochvil, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center, Department of Psychiatry

Omaha, Nebraska, United States

Countries

United States

References

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. doi: 10.1542/peds.2004-0624.

Reference Type: BACKGROUND

PMID: 15995021 (View on PubMed)

Other Identifiers

B4Z-US-X018

Identifier Type: OTHER

Identifier Source: secondary_id

11112

Identifier Type: OTHER

Identifier Source: secondary_id

0356-05-FB

Identifier Type: -

Identifier Source: org_study_id