Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

Phase 4

Completed

• Conditions: Human Endotoxaemia
• Interventions: Drug: Melatonin

• Registration Number: NCT01087359
• Lead Sponsor: Herlev Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Study Start: 2010-06
• Status Verified: 2010-10
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Last Update Submitted: 2011-06-17
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LPS + placebo night	Melatonin	-
LPS + melatonin day	Melatonin	-
LPS + placebo day	Melatonin	-
LPS + melatonin night	Melatonin	-
LPS night	Melatonin	-
LPS day	Melatonin	-

Primary Outcome Measures

Name	Time	Method
Inflammatoric markers	measured before and after the administration of LPS endotoxin.	IL-6 TNF-alpha YKL-40
Oxidative markers	measured before and after the administration of LPS endotoxin.	Vit C MDA (malondialdehyde)

Secondary Outcome Measures

Name	Time	Method
Secondary outcome	constant measurment	Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark