Trial Outcomes & Findings for Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication (NCT NCT00561340)
NCT ID: NCT00561340
Last Updated: 2023-10-04
Results Overview
Change in weight observed from baseline to 6 months
COMPLETED
NA
29 participants
6 months
2023-10-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
|
Overall Study
COMPLETED
|
7
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
refused to drink pediasure
|
6
|
0
|
Baseline Characteristics
Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication
Baseline characteristics by cohort
| Measure |
1 Can of Pediasure Supplement Plus Nutritional Counseling
n=13 Participants
Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling
|
Counseling by the Provider on Ways to Encourage Caloric Intake
n=16 Participants
Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
ADHD treatment status
Prior Active ADHD Treatment
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
ADHD treatment status
Prior Placebo Treatment
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.
Change in weight observed from baseline to 6 months
Outcome measures
| Measure |
1 Can of Pediasure Supplement Plus Nutritional Counseling
n=13 Participants
Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling
|
Counseling by the Provider on Ways to Encourage Caloric Intake
n=16 Participants
Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only
|
|---|---|---|
|
Weight Change
|
0.37 kilograms
Standard Deviation 0.54
|
-0.04 kilograms
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.
Change in height from baseline to 6 months
Outcome measures
| Measure |
1 Can of Pediasure Supplement Plus Nutritional Counseling
n=13 Participants
Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling
|
Counseling by the Provider on Ways to Encourage Caloric Intake
n=16 Participants
Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only
|
|---|---|---|
|
Height Change
|
1.85 centimeters
Standard Deviation 0.31
|
1.96 centimeters
Standard Deviation 0.44
|
Adverse Events
1 Can of Pediasure Supplement Plus Nutritional Counseling
Counseling by the Provider on Ways to Encourage Caloric Intake
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christopher Kratochvil
University of Nebraska Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place