The Role of Melatonin in the Regulation of Blood Coagulation

NCT01741389 | Completed Phase 1

• 1 other identifier: 2009/295
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injured, Tetraplegia

Keywords

Circadian variation, hemostasis, melatonin, tetraplegia

Outcome Measures

Primary Outcomes (1)

• Circadian variation of hemostatic factors

  24 hours

Study Arms (2)

Sleep only

PLACEBO COMPARATOR

Placebo given at night to tetraplegic individuals before going to sleep,

Drug: Melatonin ("Circadin")

Melatonin

ACTIVE COMPARATOR

Melatonin given at night to tetraplegic individuals before going to sleep.

Drug: Melatonin ("Circadin")

Interventions

Melatonin ("Circadin") DRUG

Melatonin; Sleep only

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Both groups:
• Those with acute or chronic co-morbidity.
• Unable to cooperate.
• Not provided written consent to participate.

Sponsors & Collaborators

• University of Oslo: lead
• Sunnaas Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Sunnaas Hospital

Nesodden, Nesodden, 1450, Norway

Location

Related Publications (3)

• 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.

  PMID: 16879232 BACKGROUND

• 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.

  PMID: 21297449 BACKGROUND

• 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.

  PMID: 16139333 BACKGROUND

MeSH Terms

Conditions

Quadriplegia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

NO (1)