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Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

Primary Purpose

Human Endotoxaemia

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Melatonin
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Endotoxaemia

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergia to melatonin
  • Women
  • Smoking.
  • Alcohol abuse.

Sites / Locations

  • Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

LPS + melatonin night

LPS + placebo night

LPS + melatonin day

LPS + placebo day

LPS night

LPS day

Arm Description

Outcomes

Primary Outcome Measures

Inflammatoric markers
IL-6 TNF-alpha YKL-40
Oxidative markers
Vit C MDA (malondialdehyde)

Secondary Outcome Measures

Secondary outcome
Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature

Full Information

First Posted
March 15, 2010
Last Updated
June 17, 2011
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01087359
Brief Title
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Official Title
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Endotoxaemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LPS + melatonin night
Arm Type
Active Comparator
Arm Title
LPS + placebo night
Arm Type
Placebo Comparator
Arm Title
LPS + melatonin day
Arm Type
Active Comparator
Arm Title
LPS + placebo day
Arm Type
Placebo Comparator
Arm Title
LPS night
Arm Type
Experimental
Arm Title
LPS day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Primary Outcome Measure Information:
Title
Inflammatoric markers
Description
IL-6 TNF-alpha YKL-40
Time Frame
measured before and after the administration of LPS endotoxin.
Title
Oxidative markers
Description
Vit C MDA (malondialdehyde)
Time Frame
measured before and after the administration of LPS endotoxin.
Secondary Outcome Measure Information:
Title
Secondary outcome
Description
Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature
Time Frame
constant measurment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

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Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

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