Condition category
Infections and Infestations
Date applied
29/02/2012
Date assigned
24/04/2012
Last edited
19/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients who are admitted to an Intensive Care Unit with severe infections (called sepsis) have a very high risk of death. We have shown in laboratory studies that melatonin can be of benefit. This is because melatonin is a very powerful antioxidant and can protect cells and organs against the damage caused by severe infections. We would like to give melatonin to patients with sepsis but we need to get some key information in healthy subjects first so we can decide what dose to give. In this study we will give groups of healthy men different doses of melatonin to provide crucial information for a further study (clinical trial) of melatonin in patients with sepsis. The main aim is to see how well different doses of melatonin are tolerated. We will also measure levels of melatonin and related substances in the blood and urine This will tell us how quickly the doses are processed in the body. If we find that melatonin is able to protect cells in patients with sepsis, this might mean treatment will also reduce the death rate.

Who can participate?
Male participants, aged between 18 and 30 years old, weighing less than 100kg, not taking any medication.

What does the study involve?
Participants will be given a single dose of melatonin (20-100mg) as oral capsules and will be monitored for 6 hours. This will include heart rate, temperature, blood pressure and also blood sampling and urine collection. A week later participants will fill in a questionnaire. The doses given will gradually increase, with each group of 5 people getting the same dose. The decision to increase the dose will be made by an independent groups of doctors, not the researchers.

What are the possible benefits and risks of participating?
Melatonin is a naturally occurring hormone which controls the sleep wake cycle. Melatonin manufactured as a drug has been used for several years as a treatment for jet lag. It has also been used in other clinical studies in various doses and the only common side effect is drowsiness. There have been some rare reports of slight nausea with very high doses but other side effects have not been reported. The needle used to put a tube into a vein to take blood samples may sting a bit and may cause bruising but this is likely to be very transient. There is no direct benefit to taking part but the study will provide essential information which will help decide what dose of melatonin to give to patients in the future.

Where is the study run from?
At Aberdeen Royal Infirmary in Scotland and is organised by researchers at the University of Aberdeen (UK)

When is the study starting and how long is it expected to run for?
June 2012 and will last for 1 year

Who is funding the study?
Chief Scientist Office (Experimental and Translational Medicine Board), UK

Who is the main contact?
Professor Helen Galley
h.f.galley@abdn.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nigel R Webster

ORCID ID

Contact details

University of Aberdeen
Institute of Medical Sciences
Aberdeen
AB25 2ZD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3/057/11

Study information

Scientific title

A dose escalation study of melatonin in healthy volunteers as a potential treatment for sepsis

Acronym

DAMSEL1

Study hypothesis

The aim of this proposed study is to administer melatonin to healthy volunteers to determine the tolerability at each dose and pharmacokinetics of melatonin using a standard dose escalation study design. We will measure the concentrations of melatonin and its major metabolites to determine a dosing interval and clearance.

Ethics approval

Not provided at time of registration

Study design

Single-centre phase I open-label dose-escalation study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact damsel.study@gmail.com to request a patient information sheet

Condition

Sepsis

Intervention

Oral melatonin, 20-100mg, single dose in cohorts of 5 subjects

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measures

Tolerance of the oral melatonin dose with no adverse events and approval by the Data Monitoring Committee to proceed to the next dose

Secondary outcome measures

Plasma levels and clearance of melatonin/metabolites at different doses measured at intervals up to 6 hours

Overall trial start date

01/06/2012

Overall trial end date

14/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. Aged 18-30 years
3. <100kg
4. Not taking medication

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Female
2. <18 or >30 years
3. >100kg
4. Taking regular medication

Recruitment start date

01/06/2012

Recruitment end date

14/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Intensive Care Unit
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Sponsor type

University/education

Website

http://www.abdn.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office (UK) ref: ETM/167

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24650045

Publication citations

Additional files

Editorial Notes

19/02/2016: Publication reference added.