Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

Phase 3

Completed

• Conditions: Delirium
• Interventions: Dietary Supplement: melatonin; Dietary Supplement: placebo

• Registration Number: NCT00873379
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-02
• Study Completion: 2008-03
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-06
• Last Update Posted: 2009-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
melatonin	melatonin	.5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380)
placebo	placebo	half a white placebo tablet

Primary Outcome Measures

Name	Time	Method
delirious using confusion assessment method (CAM)	days

Secondary Outcome Measures

Name	Time	Method
MDAS (memorial delirium assessment scale)	days

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada