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This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days:
Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPS + melatonin night | Active Comparator |
| |
| LPS + placebo night | Placebo Comparator |
| |
| LPS + melatonin day | Active Comparator |
| |
| LPS + placebo day | Placebo Comparator |
| |
| LPS night | Experimental |
| |
| LPS day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatoric markers | IL-6 TNF-alpha YKL-40 | measured before and after the administration of LPS endotoxin. |
| Oxidative markers | Vit C MDA (malondialdehyde) | measured before and after the administration of LPS endotoxin. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome | Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature | constant measurment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |