Effect of Melatonin Versus Placebo for Prevention of Delirium Among Medically Hospitalized Patients: Study Protocol for a Single-Center, Double-Blinded, Randomised Controlled Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The high prevalence of delirium in hospitalized older adults, with significant associated morbidity and mortality, emphasize the need for effective prevention strategies. Limited trials have explored melatonin's potential in preventing delirium among patients admitted to general medical wards. Previous trials on melatonin's preventive role in medical wards had limitations, necessitating a robust, double-blinded, placebo-controlled design with a larger sample size. This randomized, double-blind study of melatonin versus placebo aims to investigate the efficacy of melatonin, a neurohormone regulating the sleep-wake cycle, in preventing delirium among medically hospitalized patients aged 65 or older. Given the high prevalence of delirium in this population and its association with adverse outcomes, the study seeks to contribute valuable insights into an effective preventive strategy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit
Locations
Other Locations
Oman
Sultan Qaboos University Hospital
RECRUITING
Muscat
Sultan Qaboos University Hospital
NOT_YET_RECRUITING
Muscat
Contact Information
Primary
Abdullah M Al Alawi, FRACP
dr.abdullahalalawi@gmail.com
+96895384990
Backup
Juhaina Salim Al Maqbali, MSc
juhaina@squ.edu.om
Time Frame
Start Date:2024-09-30
Estimated Completion Date:2025-06
Participants
Target number of participants:240
Treatments
Experimental: Melatonin 5mg/day
Intervention group 1: Melatonin 5mg/day~* Study drug will be given at 20:00 - 22:00 daily, starting on the day of enrolment until discharge, death, or up to 5 days as most medically hospitalised patients at great risk of delirium in the first few days of admission.(20)~* The study medication will be given by mouth or if needed, via the feeding tube followed by a flush with 20mL water.
Experimental: Melatonin 8 mg/day
Intervention group 2:Study drug will be given at 20:00 - 22:00 daily, starting on the day of enrolment until discharge, death, or up to 5 days as most medically hospitalised patients at great risk of delirium in the first few days of admission.(20)~• The study medication will be given by mouth or if needed, via the feeding tube followed by a flush with 20mL water.
Placebo_comparator: Placebo
* Study drug will be given at 20:00 - 22:00 daily, starting on the day of enrolment until discharge, death, or up to 5 days as most medically hospitalised patients at great risk of delirium in the first few days of admission. (20)~* The study medication will be given by mouth or if needed, via the feeding tube followed by a flush with 20mL water.