The Role of Melatonin in the Regulation of Blood Coagulation (COME)

University of Oslo

Status and phase: Completed; Phase 1

Conditions: Spinal Cord Injured, Tetraplegia

Treatments: Drug: Melatonin ("Circadin")

Study type: Interventional

Funder types: Other

Identifiers

NCT01741389

2009/295

Details and patient eligibility

About

The main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control subjects.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Intervention group:

• A diagnosis of tetraplegia for at least 2 years, and otherwise healthy.
• Must not use drugs permanently (except anti-spasmolytics).
• Must be able to swallow tablets.
• Must give written consent to participate.

Control group:

• Must be healthy.
• Must not use drugs permanently.
• Must give written consent to participate.

Exclusion criteria

Both groups:

• Those with acute or chronic co-morbidity.
• Unable to cooperate.
• Not provided written consent to participate.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Sleep only

Placebo Comparator group

Description:

Placebo given at night to tetraplegic individuals before going to sleep,

Treatment:

Drug: Melatonin ("Circadin")

Melatonin

Active Comparator group

Description:

Melatonin given at night to tetraplegic individuals before going to sleep.

Treatment:

Drug: Melatonin ("Circadin")