Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

Human Endotoxaemia Clinical Trial

Official title:

Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087359
• Other study ID #: H-2-2010-010
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2010
• Last updated: June 17, 2011
• Start date: June 2010
• Est. completion date: February 2011

Study information

• Verified date: October 2010
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endotoxemia
• Human Endotoxaemia

Intervention

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

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatoric markers	IL-6 TNF-alpha YKL-40	measured before and after the administration of LPS endotoxin.	No
Primary	Oxidative markers	Vit C MDA (malondialdehyde)	measured before and after the administration of LPS endotoxin.	No
Secondary	Secondary outcome	Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature	constant measurment	No