Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
NCT01087359 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2011-06-20
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.
Conditions
- Human Endotoxaemia
Interventions
- DRUG
-
Melatonin
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Sponsors & Collaborators
-
Herlev Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2011-01-31
- Completion
- 2011-02-28
Countries
- Denmark
Study Locations
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