Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

This study has been completed.
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00873379
First received: March 31, 2009
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Delirium
Dietary Supplement: melatonin
Dietary Supplement: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • delirious using confusion assessment method (CAM) [ Time Frame: days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MDAS (memorial delirium assessment scale) [ Time Frame: days ] [ Designated as safety issue: Yes ]

Enrollment: 122
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873379

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Chris brymer, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00873379     History of Changes
Other Study ID Numbers: R-07-314, 13426
Study First Received: March 31, 2009
Last Updated: July 6, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014