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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher J. Kratochvil, M.D., University of Nebraska
ClinicalTrials.gov Identifier:
NCT00561340
First received: November 16, 2007
Last updated: January 25, 2015
Last verified: January 2015
Results First Received: December 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: ADHD
Interventions: Dietary Supplement: Pediasure
Behavioral: Nutritional counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
33 subjects total were eligible for participation in this study. 29 were enrolled and are included in the analysis. All patients had previously completed an 8-week double-blind placebo-controlled study of atomoxetine for the treatment of ADHD in 5 and 6 year olds.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
25 subjects were randomized to one of the 2 treatment groups. An additional 4 subjects for whom randomization to caloric supplementation was inappropriate were included in the nutritional counseling only arm for purposes of analysis as they did enroll in this study.

Reporting Groups
  Description
1 Can of Pediasure Supplement Plus Nutritional Counseling

Pediasure and nutritional counseling

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

Counseling by the Provider on Ways to Encourage Caloric Intake

Behavioral intervention - Nutritional Counseling

Nutritional counseling: 50% randomized to nutritional counseling only


Participant Flow:   Overall Study
    1 Can of Pediasure Supplement Plus Nutritional Counseling     Counseling by the Provider on Ways to Encourage Caloric Intake  
STARTED     13     16  
COMPLETED     7     16  
NOT COMPLETED     6     0  
refused to drink pediasure                 6                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 25 subjects were eligible for randomization. 4 subjects were not appropriate for randomization to caloric supplementation with pediasure so were included in the counseling only arm.

Reporting Groups
  Description
1 Can of Pediasure Supplement Plus Nutritional Counseling

Pediasure and nutritional counseling

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

Counseling by the Provider on Ways to Encourage Caloric Intake

Behavioral intervention - Nutritional Counseling

Nutritional counseling: 50% randomized to nutritional counseling only

Total Total of all reporting groups

Baseline Measures
    1 Can of Pediasure Supplement Plus Nutritional Counseling     Counseling by the Provider on Ways to Encourage Caloric Intake     Total  
Number of Participants  
[units: participants]
  13     16     29  
Age  
[units: participants]
     
<=18 years     13     16     29  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     5     5     10  
Male     8     11     19  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     1     2  
Not Hispanic or Latino     12     15     27  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     11     12     23  
More than one race     1     2     3  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     13     16     29  
ADHD treatment status  
[units: participants]
     
Prior Active ADHD Treatment     8     6     14  
Prior Placebo Treatment     5     10     15  



  Outcome Measures
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1.  Primary:   Weight Change   [ Time Frame: 6 months ]

2.  Primary:   Height Change   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christopher Kratochvil
Organization: University of Nebraska Medical Center
phone: 4025526005
e-mail: ckratoch@unmc.edu


Publications:

Responsible Party: Christopher J. Kratochvil, M.D., University of Nebraska
ClinicalTrials.gov Identifier: NCT00561340     History of Changes
Other Study ID Numbers: 356-05-FB
B4Z-US-X018 ( Other Identifier: Eli Lilly and Company )
11112 ( Other Identifier: Abbott Laboratories )
Study First Received: November 16, 2007
Results First Received: December 29, 2014
Last Updated: January 25, 2015
Health Authority: United States: Institutional Review Board