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OpenTrials
Completed

NCT Number: NCT01087359

Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

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.

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Key information

Conditions

Human Endotoxaemia

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Herlev Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergia to melatonin
  • Women
  • Smoking.
  • Alcohol abuse.

Treatment and study plan

Melatonin

Drug

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

Primary outcomes

  1. Inflammatoric markers

    Time frame: measured before and after the administration of LPS endotoxin.

    IL-6 TNF-alpha YKL-40

  2. Oxidative markers

    Time frame: measured before and after the administration of LPS endotoxin.

    Vit C MDA (malondialdehyde)

Secondary outcomes

  1. Secondary outcome

    Time frame: constant measurment

    Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2010
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.