Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly
Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00873379
Collaborator
University of Western Ontario, Canada (Other)
122
1
2
5
24.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial
Study Start Date
:
Oct 1, 2007
Actual Primary Completion Date
:
Feb 1, 2008
Actual Study Completion Date
:
Mar 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: melatonin .5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380) |
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 Comparator: placebo half a white placebo tablet |
Dietary Supplement: placebo
half a white placebo tablet
|
Outcome Measures
Primary Outcome Measures
- delirious using confusion assessment method (CAM) [days]
Secondary Outcome Measures
- MDAS (memorial delirium assessment scale) [days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | London Health Sciences Centre | London | Ontario | Canada | n6a5a5 |
Sponsors and Collaborators
- Lawson Health Research Institute
- University of Western Ontario, Canada
Investigators
- Principal Investigator: Chris Brymer, MD, University of Western Ontario, Canada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00873379
Other Study ID Numbers:
- R-07-314
- 13426
First Posted:
Apr 1, 2009
Last Update Posted:
Jul 7, 2009
Last Verified:
Jul 1, 2009