ADHD
Conditions
Keywords
ADHD, Growth, Atomoxetine, Pediasure
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.
Interventions
DIETARY_SUPPLEMENTPediasure
50% will be randomized to pediasure with nutritional counseling
BEHAVIORALNutritional counseling
50% randomized to nutritional counseling only
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | 6 months | Change in weight observed from baseline to 6 months |
| Height Change | 6 months | Change in height from baseline to 6 months |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 1 Can of Pediasure Supplement Plus Nutritional Counseling Pediasure and nutritional counseling
Pediasure: 50% will be randomized to pediasure with nutritional counseling | 13 |
| Counseling by the Provider on Ways to Encourage Caloric Intake Behavioral intervention - Nutritional Counseling
Nutritional counseling: 50% randomized to nutritional counseling only | 16 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | refused to drink pediasure | 6 | 0 |
Baseline characteristics
| Characteristic | 1 Can of Pediasure Supplement Plus Nutritional Counseling | Counseling by the Provider on Ways to Encourage Caloric Intake | Total |
|---|---|---|---|
| ADHD treatment status Prior Active ADHD Treatment | 8 participants | 6 participants | 14 participants |
| ADHD treatment status Prior Placebo Treatment | 5 participants | 10 participants | 15 participants |
| Age, Categorical <=18 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 15 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 12 Participants | 23 Participants |
| Region of Enrollment United States | 13 participants | 16 participants | 29 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 16 |
| other Total, other adverse events | 0 / 13 | 0 / 16 |
| serious Total, serious adverse events | 0 / 13 | 0 / 16 |
Outcome results
Primary
Height Change
Change in height from baseline to 6 months
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Can of Pediasure Supplement Plus Nutritional Counseling | Height Change | 1.85 centimeters | Standard Deviation 0.31 |
| Counseling by the Provider on Ways to Encourage Caloric Intake | Height Change | 1.96 centimeters | Standard Deviation 0.44 |
Primary
Weight Change
Change in weight observed from baseline to 6 months
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Can of Pediasure Supplement Plus Nutritional Counseling | Weight Change | 0.37 kilograms | Standard Deviation 0.54 |
| Counseling by the Provider on Ways to Encourage Caloric Intake | Weight Change | -0.04 kilograms | Standard Deviation 0.33 |