Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

Lawson Health Research Institute

Status and phase: Completed; Phase 3

Conditions: Delirium

Treatments: Dietary Supplement: placebo; Dietary Supplement: melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT00873379

13426

R-07-314

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups, including a placebo group

melatonin

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: melatonin

placebo

Placebo Comparator group

Description:

half a white placebo tablet

Treatment:

Dietary Supplement: placebo