The Role of Melatonin in the Regulation of Blood Coagulation (COME)
Primary Purpose
Spinal Cord Injured, Tetraplegia
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Melatonin ("Circadin")
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Cord Injured, Tetraplegia focused on measuring Circadian variation, hemostasis, melatonin, tetraplegia
Eligibility 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.
Sites / Locations
- Sunnaas Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sleep only
Melatonin
Arm Description
Placebo given at night to tetraplegic individuals before going to sleep,
Melatonin given at night to tetraplegic individuals before going to sleep.
Outcomes
Primary Outcome Measures
Circadian variation of hemostatic factors
Secondary Outcome Measures
Full Information
NCT ID
NCT01741389
First Posted
November 30, 2012
Last Updated
October 13, 2017
Sponsor
University of Oslo
Collaborators
Sunnaas Hospital, Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01741389
Brief Title
The Role of Melatonin in the Regulation of Blood Coagulation
Acronym
COME
Official Title
The Role of Melatonin in the Regulation of Blood Coagulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Sunnaas Hospital, Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injured, Tetraplegia
Keywords
Circadian variation, hemostasis, melatonin, tetraplegia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep only
Arm Type
Placebo Comparator
Arm Description
Placebo given at night to tetraplegic individuals before going to sleep,
Arm Title
Melatonin
Arm Type
Active Comparator
Arm Description
Melatonin given at night to tetraplegic individuals before going to sleep.
Intervention Type
Drug
Intervention Name(s)
Melatonin ("Circadin")
Primary Outcome Measure Information:
Title
Circadian variation of hemostatic factors
Time Frame
24 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Sunnaas Hospital
City
Nesodden
ZIP/Postal Code
1450
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
16879232
Citation
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.
Results Reference
background
PubMed Identifier
21297449
Citation
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.
Results Reference
background
PubMed Identifier
16139333
Citation
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.
Results Reference
background
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The Role of Melatonin in the Regulation of Blood Coagulation
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