Clinical Trial: Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

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 Summary:
Sponsor: Herlev Hospital

Current Primary Outcome:

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

Original Primary Outcome:

• Oxidative markers
  Vit C Malondialdehyde F2-isoprostanes
• Inflammatoric markers
  IL-6 TNF-alpha YKL-40

Current Secondary Outcome: Secondary outcome [ Time Frame: constant measurment ]

Original Secondary Outcome: Secondary outcome

Information By: Herlev Hospital

Dates:
Date Received: March 15, 2010
Date Started: June 2010
Date Completion:
Last Updated: June 17, 2011
Last Verified: October 2010