The Role of Melatonin in the Regulation of Blood Coagulation

University of Oslo12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Spinal Cord Injured, Tetraplegia

Interventions

Melatonin ("Circadin")DRUG

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sunnaas Hospital

Nesodden, Nesodden, Norway

Outcomes

Primary Outcomes

Circadian variation of hemostatic factors

Time frame: 24 hours

Data from ClinicalTrials.gov

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