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

This study has been completed.
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: March 9, 2014
Last verified: March 2014
  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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of Melatonin in the Regulation of Blood Coagulation

Resource links provided by NLM:


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 ]

Enrollment: 12
Study Start Date: December 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 9, 2014
Health Authority: Norway: Regional Ethics Commitee

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

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

ClinicalTrials.gov processed this record on October 23, 2014