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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

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date October 16, 2017
Study Start Date  ICMJE December 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
Circadian variation of hemostatic factors [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01741389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Melatonin in the Regulation of Blood Coagulation
Official Title  ICMJE The Role of Melatonin in the Regulation of Blood Coagulation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Spinal Cord Injured, Tetraplegia
Intervention  ICMJE Drug: Melatonin ("Circadin")
Study Arms  ICMJE
  • Placebo Comparator: Sleep only
    Placebo given at night to tetraplegic individuals before going to sleep,
    Intervention: Drug: Melatonin ("Circadin")
  • Active Comparator: Melatonin
    Melatonin given at night to tetraplegic individuals before going to sleep.
    Intervention: Drug: Melatonin ("Circadin")
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741389
Other Study ID Numbers  ICMJE 2009/295
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Per Ole Iversen, MD, University of Oslo
Study Sponsor  ICMJE University of Oslo
Collaborators  ICMJE
  • Sunnaas Hospital
  • Oslo University Hospital
Investigators  ICMJE Not Provided
PRS Account University of Oslo
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP