The Role of Melatonin in the Regulation of Blood Coagulation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01741389

Acronym

COME

Enrollment

Registered

2012-12-04

Start date

2012-12-31

Completion date

2014-03-31

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injured, Tetraplegia

Keywords

Circadian variation, hemostasis, melatonin, tetraplegia

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.

Interventions

DRUGMelatonin (Circadin)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Circadian variation of hemostatic factors	24 hours

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026