Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

NCT ID: NCT01087359

Last Updated: 2011-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Human Endotoxaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LPS + melatonin night

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo

LPS + placebo night

Group Type PLACEBO_COMPARATOR

Melatonin

Intervention Type DRUG

100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo

LPS + melatonin day

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo

LPS + placebo day

Group Type PLACEBO_COMPARATOR

Melatonin

Intervention Type DRUG

100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo

LPS night

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo

LPS day

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo

Interventions

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Melatonin

100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Allergia to melatonin
* Women
* Smoking.
* Alcohol abuse.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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MA

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2010-010

Identifier Type: -

Identifier Source: org_study_id

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