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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561340
• Other study ID #: 0356-05-FB
• Secondary ID: B4Z-US-X01811112
• Status: Completed
• Phase: N/A
• Start date: January 2, 2006
• Est. completion date: September 1, 2010

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 1, 2010
• Est. primary completion date: September 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Dietary Supplement:
• Pediasure
50% will be randomized to pediasure with nutritional counseling

Behavioral:
• Nutritional counseling
50% randomized to nutritional counseling only

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Department of Psychiatry	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	Change in weight observed from baseline to 6 months	6 months
Primary	Height Change	Change in height from baseline to 6 months	6 months