Dose escAlation study of Melatonin in Sepsis: healthy voLunteers
| ISRCTN | ISRCTN17088991 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17088991 |
| ClinicalTrials.gov number | NCT01724424 |
| Secondary identifying numbers | 3/057/11 |
- Submission date
- 29/02/2012
- Registration date
- 24/04/2012
- Last edited
- 29/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
University of Aberdeen
Institute of Medical Sciences
Aberdeen
AB25 2ZD
United Kingdom
Study information
| Study design | Single-centre phase I open-label dose-escalation study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact damsel.study@gmail.com to request a patient information sheet |
| Scientific title | A dose escalation study of melatonin in healthy volunteers as a potential treatment for sepsis |
| Study acronym | DAMSEL1 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sepsis |
| Intervention | Oral melatonin, 20-100mg, single dose in cohorts of 5 subjects |
| Intervention type | Other |
| 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 study start date | 01/06/2012 |
| Completion date | 14/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Male |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Male 2. Aged 18-30 years 3. <100kg 4. Not taking medication |
| Key exclusion criteria | 1. Female 2. <18 or >30 years 3. >100kg 4. Taking regular medication |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 14/06/2013 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Aberdeen
AB25 2ZN
United Kingdom
Sponsor information
University/education
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
Scotland
United Kingdom
| Website | http://www.abdn.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2014 | Yes | No |
Editorial Notes
29/08/2019: ClinicalTrials.gov number added.
19/02/2016: Publication reference added.
