NCT00873379已完成3 期
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- delirious using confusion assessment method (CAM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.
排除标准
- •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.
研究组 & 干预措施
placebo
Placebo Comparator
half a white placebo tablet
干预措施: placebo (Dietary Supplement)
melatonin
Active Comparator
.5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380)
干预措施: melatonin (Dietary Supplement)
结局指标
主要结局
delirious using confusion assessment method (CAM)
时间窗: days
次要结局
- MDAS (memorial delirium assessment scale)(days)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Prevention of Delirium in Inpatients Utilizing MelatoninDeliriumNCT02654314Yale University277
已完成
不适用
Diagnosis of Delirium and Assessment of Sleep Quality in Patients in the Anesthesia and Intensive Care UnitDelirium and InsomniaNCT06699004Sakarya University107
Unknown
4 期
Melatonin Use in the Intensive Care Elderly PopulationMelatoninDeliriumNCT03013790MICE Trial Group600
Unknown
不适用
Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency DepartmentDelirium in Old AgeNCT04187807Universidad Autonoma de San Luis Potosí145
已完成
不适用
Can Melatonin prevent delirium in ICU patients or not ?CTRI/2021/10/037315All India Institute of Medical Sciences New Delhi50