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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sunnaas Hospital
Oslo University Hospital
Information provided by (Responsible Party):
Per Ole Iversen, MD, University of Oslo
ClinicalTrials.gov Identifier:
NCT01741389
First received: November 30, 2012
Last updated: January 12, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Spinal Cord Injured, Tetraplegia
 Drug: Melatonin ("Circadin")
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: The Role of Melatonin in the Regulation of Blood Coagulation

Resource links provided by NLM:

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

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Circadian variation of hemostatic factors [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sleep only
Placebo given at night to tetraplegic individuals before going to sleep,
Active Comparator: Melatonin
Melatonin given at night to tetraplegic individuals before going to sleep.
 Drug: Melatonin ("Circadin")

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741389

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

Publications:

Responsible Party: Per Ole Iversen, MD, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01741389     History of Changes
Other Study ID Numbers: 2009/295
Study First Received: November 30, 2012
Last Updated: January 12, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by University of Oslo:
Circadian variation, hemostasis, melatonin, tetraplegia

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

ClinicalTrials.gov processed this record on May 22, 2013