N/A
Completed N=29
Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication
Source: ClinicalTrials.gov NCT00561340 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Weight Change — 0.37; -0.04 kilograms
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change |
0.37; -0.04 | — |
| PRIMARY Height Change |
1.85; 1.96 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00561340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.