NCT01087359

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 20, 2011

Status Verified

October 1, 2010

Enrollment Period

7 months

First QC Date

March 15, 2010

Last Update Submit

June 17, 2011

Conditions

Human Endotoxaemia

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (1)

  • Secondary outcome

    constant measurment

Study Arms (6)

LPS + melatonin night

ACTIVE COMPARATOR
Drug: Melatonin

LPS + placebo night

PLACEBO COMPARATOR
Drug: Melatonin

LPS + melatonin day

ACTIVE COMPARATOR
Drug: Melatonin

LPS + placebo day

PLACEBO COMPARATOR
Drug: Melatonin

LPS night

EXPERIMENTAL
Drug: Melatonin

LPS day

EXPERIMENTAL
Drug: Melatonin

Interventions

MelatoninDRUG

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

LPS + melatonin dayLPS + melatonin nightLPS + placebo dayLPS + placebo nightLPS dayLPS night

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 16, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

June 20, 2011

Record last verified: 2010-10

Locations

DK(1)