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

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ClinicalTrials.gov Identifier: NCT01741389
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : October 16, 2017
Sponsor:
Collaborators:
Sunnaas Hospital
Oslo University Hospital
Information provided by (Responsible Party):
Per Ole Iversen, MD, 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injured, Tetraplegia Drug: Melatonin ("Circadin") Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of Melatonin in the Regulation of Blood Coagulation
Study Start Date : December 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

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")



Primary Outcome Measures :
  1. Circadian variation of hemostatic factors [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741389


Locations
Norway
Sunnaas Hospital
Nesodden, Norway, 1450
Sponsors and Collaborators
University of Oslo
Sunnaas Hospital
Oslo University Hospital

Publications:
Responsible Party: Per Ole Iversen, MD, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01741389     History of Changes
Other Study ID Numbers: 2009/295
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by Per Ole Iversen, MD, University of Oslo:
Circadian variation, hemostasis, melatonin, tetraplegia

Additional relevant MeSH terms:
Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants