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 markersVit C Malondialdehyde F2-isoprostanes
- Inflammatoric markersIL-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