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Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00873379
Enrollment
122
Registered
2009-04-01
Start date
2007-10-31
Completion date
2008-03-31
Last updated
2009-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Brief summary

122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.

Interventions

DIETARY_SUPPLEMENTmelatonin

one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada

DIETARY_SUPPLEMENTplacebo

half a white placebo tablet

Sponsors

University of Western Ontario, Canada
CollaboratorOTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.

Exclusion criteria

* Life expectancy less than 24 hours, * Unable to communicate in English, * Unable to take oral medications, * Intracranial bleed or known seizure disorder, * Markedly sub or supra-therapeutic INR while on warfarin, OR * A known allergy to study tablet ingredients.

Design outcomes

Primary

MeasureTime frame
delirious using confusion assessment method (CAM)days

Secondary

MeasureTime frame
MDAS (memorial delirium assessment scale)days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026