Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

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

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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