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Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

H

Herlev Hospital

Status and phase

Completed
Phase 4

Conditions

Human Endotoxaemia

Treatments

Drug: Melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT01087359
H-2-2010-010

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 6 patient groups, including a placebo group

LPS + melatonin night
Active Comparator group
Treatment:
Drug: Melatonin
LPS + placebo night
Placebo Comparator group
Treatment:
Drug: Melatonin
LPS + melatonin day
Active Comparator group
Treatment:
Drug: Melatonin
LPS + placebo day
Placebo Comparator group
Treatment:
Drug: Melatonin
LPS night
Experimental group
Treatment:
Drug: Melatonin
LPS day
Experimental group
Treatment:
Drug: Melatonin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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