The Role of Melatonin in the Regulation of Blood Coagulation
NCT ID: NCT01741389
Last Updated: 2017-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2012-12-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Sleep only
Placebo given at night to tetraplegic individuals before going to sleep,
Melatonin ("Circadin")
Melatonin
Melatonin given at night to tetraplegic individuals before going to sleep.
Melatonin ("Circadin")
Interventions
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Melatonin ("Circadin")
Eligibility Criteria
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Inclusion Criteria
* 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
* Those with acute or chronic co-morbidity.
* Unable to cooperate.
* Not provided written consent to participate.
18 Years
MALE
Yes
Sponsors
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Sunnaas Hospital
UNKNOWN
Oslo University Hospital
OTHER
University of Oslo
OTHER
Responsible Party
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Per Ole Iversen, MD
Professor
Locations
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Sunnaas Hospital
Nesodden, Nesodden, Norway
Countries
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References
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Dahm A, Osterud B, Hjeltnes N, Sandset PM, Iversen PO. Opposite circadian rhythms in melatonin and tissue factor pathway inhibitor type 1: does daylight affect coagulation? J Thromb Haemost. 2006 Aug;4(8):1840-2. doi: 10.1111/j.1538-7836.2006.02048.x. No abstract available.
Kostovski E, Dahm AE, Iversen N, Hjeltnes N, Osterud B, Sandset PM, Iversen PO. Melatonin stimulates release of tissue factor pathway inhibitor from the vascular endothelium. Blood Coagul Fibrinolysis. 2011 Jun;22(4):254-9. doi: 10.1097/MBC.0b013e3283442ce2.
Dahm AE, Iversen PO, Hjeltnes N, Sandset PM. Differences in circadian variations of tissue factor pathway inhibitor type 1 between able-bodied and spinal cord injured. Thromb Res. 2006;118(2):281-7. doi: 10.1016/j.thromres.2005.07.021. Epub 2005 Aug 31.
Other Identifiers
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2009/295
Identifier Type: -
Identifier Source: org_study_id