NCT00561340 is a NA clinical trial of Pediasure in ADHD, sponsored by University of Nebraska.

Who is sponsoring NCT00561340?

NCT00561340 is sponsored by University of Nebraska.

What drugs are being tested in NCT00561340?

Interventions in NCT00561340: Pediasure, Nutritional counseling.

Is NCT00561340 still recruiting?

NCT00561340 is currently completed. Last updated 4 October 2023.

Are results published for NCT00561340?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-04 · How we verify

NCT00561340

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 4 October 2023

What this trial tests

NA trial testing Pediasure in ADHD in 29 participants. Completed in 1 September 2010.

Timeline

2 January 2006

Primary endpoint
1 September 2010

1 September 2010

Quick facts

Lead sponsor	University of Nebraska
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	2 January 2006
Primary completion	1 September 2010
Estimated completion	1 September 2010
Sites	1 location across United States

Drugs / interventions tested

Pediasure — full drug profile →
Nutritional counseling

Conditions studied

ADHD — all drugs for ADHD →

Sponsor

University of Nebraska

Who can join

Adults 5 to 9, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Weight Change Primary · 6 months

Change in weight observed from baseline to 6 months

Group	Value	95% CI
1 Can of Pediasure Supplement Plus Nutritional Counseling	0.37	± 0.54
Counseling by the Provider on Ways to Encourage Caloric Intake	-0.04	± 0.33

Height Change Primary · 6 months

Change in height from baseline to 6 months

Group	Value	95% CI
1 Can of Pediasure Supplement Plus Nutritional Counseling	1.85	± 0.31
Counseling by the Provider on Ways to Encourage Caloric Intake	1.96	± 0.44

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A double-blind, placebo-controlled study of atomoxetine in young children with ADHD.
Kratochvil CJ, Vaughan BS, Stoner JA, Daughton JM, et al · · 2011 · cited 46× · PMID 21422081 · DOI 10.1542/peds.2010-0825
Efficacy and Tolerability of Different Interventions in Children and Adolescents with Attention Deficit Hyperactivity Disorder.
Luan R, Mu Z, Yue F, He S. · · 2017 · cited 8× · PMID 29180967 · DOI 10.3389/fpsyt.2017.00229

Verify or expand the search:

Other trials of Pediasure

Trials testing the same drug.

NCT03414775 — Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children · NA · completed

Other recruiting trials for ADHD

Currently open trials in the same condition.

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Other University of Nebraska trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00561340 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
Last refreshed: 4 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00561340.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing