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Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

Primary Purpose

Delirium

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
melatonin
placebo
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

melatonin

placebo

Arm Description

.5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380)

half a white placebo tablet

Outcomes

Primary Outcome Measures

delirious using confusion assessment method (CAM)

Secondary Outcome Measures

MDAS (memorial delirium assessment scale)

Full Information

First Posted
March 31, 2009
Last Updated
July 6, 2009
Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00873379
Brief Title
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly
Official Title
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
melatonin
Arm Type
Active Comparator
Arm Description
.5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
half a white placebo tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
melatonin
Intervention Description
one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
half a white placebo tablet
Primary Outcome Measure Information:
Title
delirious using confusion assessment method (CAM)
Time Frame
days
Secondary Outcome Measure Information:
Title
MDAS (memorial delirium assessment scale)
Time Frame
days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Brymer, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
n6a5a5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

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