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Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087359
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : June 20, 2011
Sponsor:
Information provided by:
Herlev Hospital

Study Description
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Brief Summary:

This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days:

  • day 1: On day time administration of LPS.
  • day 2: On night time administration of LPS.
  • day 3: On day time administration of LPS + Placebo.
  • day 4: On day time administration of LPS + melatonin.
  • day 5: On night time administration of LPS + placebo.
  • day 6: On night time administration og LPS + melatonin.

Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.


Condition or disease Intervention/treatment Phase
Human Endotoxaemia Drug: Melatonin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Study Start Date : June 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LPS + melatonin night Drug: Melatonin
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Placebo Comparator: LPS + placebo night Drug: Melatonin
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Active Comparator: LPS + melatonin day Drug: Melatonin
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Placebo Comparator: LPS + placebo day Drug: Melatonin
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Experimental: LPS night Drug: Melatonin
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Experimental: LPS day Drug: Melatonin
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo


Outcome Measures
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Primary Outcome Measures :
  1. Inflammatoric markers [ Time Frame: measured before and after the administration of LPS endotoxin. ]
    IL-6 TNF-alpha YKL-40

  2. Oxidative markers [ Time Frame: measured before and after the administration of LPS endotoxin. ]
    Vit C MDA (malondialdehyde)


Secondary Outcome Measures :
  1. Secondary outcome [ Time Frame: constant measurment ]
    Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men
  • Age 18-49 year.
  • Healthy
  • No sleepiness disorders.
  • No medication
  • ASA I

Exclusion Criteria:

  • Allergia to melatonin
  • Women
  • Smoking.
  • Alcohol abuse.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087359


Locations
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Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
More Information
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Responsible Party: Mahdi Alamili, MA
ClinicalTrials.gov Identifier: NCT01087359    
Other Study ID Numbers: H-2-2010-010
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: October 2010
Additional relevant MeSH terms:
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Endotoxemia
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants