Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873379
• Other study ID #: R-07-314
• Secondary ID: 13426
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2009
• Last updated: July 6, 2009
• Start date: October 2007
• Est. completion date: March 2008

Study information

• Verified date: July 2009
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

Dietary Supplement:
• melatonin
one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada
• placebo
half a white placebo tablet

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delirious using confusion assessment method (CAM)		days	Yes
Secondary	MDAS (memorial delirium assessment scale)		days	Yes