Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

June 17, 2011 updated by: Herlev Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Herlev, Denmark, 2730
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: LPS + melatonin night
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
PLACEBO_COMPARATOR: LPS + placebo night
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
ACTIVE_COMPARATOR: LPS + melatonin day
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
PLACEBO_COMPARATOR: LPS + placebo day
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
EXPERIMENTAL: LPS night
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
EXPERIMENTAL: LPS day
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatoric markers
Time Frame: measured before and after the administration of LPS endotoxin.
IL-6 TNF-alpha YKL-40
measured before and after the administration of LPS endotoxin.
Oxidative markers
Time Frame: measured before and after the administration of LPS endotoxin.
Vit C MDA (malondialdehyde)
measured before and after the administration of LPS endotoxin.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome
Time Frame: constant measurment
Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature
constant measurment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (ESTIMATE)

March 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 17, 2011

Last Verified

October 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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