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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01724424
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 measure
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 (if study stopped)
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
Funders
Funder type
Government
Funder name
Chief Scientist Office (UK) ref: ETM/167
Alternative name(s)
CSO
Funding Body Type
unknown
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24650045