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

October 13, 2017 updated by: Per Ole Iversen, MD, University of Oslo
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Nesodden, Norway, 1450
        • Sunnaas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sleep only
Placebo given at night to tetraplegic individuals before going to sleep,
Drug: Melatonin ("Circadin")
Active Comparator: Melatonin
Melatonin given at night to tetraplegic individuals before going to sleep.
Drug: Melatonin ("Circadin")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Circadian variation of hemostatic factors
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Oslo University Hospital
Sunnaas Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 13, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/295

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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