NCT00561340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

February 9, 2015

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

4.7 years

First QC Date

November 16, 2007

Results QC Date

December 29, 2014

Last Update Submit

September 27, 2023

Conditions

ADHD

Keywords

ADHDGrowthAtomoxetinePediasure

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

1 Can of Pediasure Supplement Plus Nutritional Counseling

EXPERIMENTAL

Pediasure and nutritional counseling

Dietary Supplement: PediasureBehavioral: Nutritional counseling

Counseling by the Provider on Ways to Encourage Caloric Intake

ACTIVE COMPARATOR

Behavioral intervention - Nutritional Counseling

Behavioral: Nutritional counseling

Interventions

PediasureDIETARY_SUPPLEMENT

50% will be randomized to pediasure with nutritional counseling

1 Can of Pediasure Supplement Plus Nutritional Counseling
Nutritional counselingBEHAVIORAL

50% randomized to nutritional counseling only

1 Can of Pediasure Supplement Plus Nutritional CounselingCounseling by the Provider on Ways to Encourage Caloric Intake

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Parents who are unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Department of Psychiatry

Omaha, Nebraska, 68105, United States

Location

Related 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.

    PMID: 15995021BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Limitations and Caveats

This is a follow-up study of 5 and 6 year olds who completed a DBPC study of atomoxetine for ADHD. Data is confounded by subjects having entered the study on different pre-study and concurrent pharmacotherapy. The population is small.

Results Point of Contact

Title
Christopher Kratochvil
Organization
University of Nebraska Medical Center
ckratoch@unmc.edu
402-552-6005

Study Officials

  • Christopher J Kratochvil, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 20, 2007

Study Start

January 2, 2006

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 4, 2023

Results First Posted

February 9, 2015

Record last verified: 2023-09

Locations

US(1)