The Role of Melatonin in the Regulation of Blood Coagulation

Phase 1

Completed

• Conditions: Spinal Cord Injured, Tetraplegia
• Interventions: Drug: Melatonin ("Circadin")

• Registration Number: NCT01741389
• Lead Sponsor: University of Oslo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-30
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-04
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sleep only	Melatonin ("Circadin")	Placebo given at night to tetraplegic individuals before going to sleep,
Melatonin	Melatonin ("Circadin")	Melatonin given at night to tetraplegic individuals before going to sleep.

Primary Outcome Measures

Name	Time	Method
Circadian variation of hemostatic factors	24 hours

Trial Locations

Locations (1)

Sunnaas Hospital; 🇳🇴 Nesodden, Norway