- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01087359
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
June 17, 2011 updated by: Herlev Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Herlev, Denmark, 2730
- Herlev Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men
- Age 18-49 year.
- Healthy
- No sleepiness disorders.
- No medication
- ASA I
Exclusion Criteria:
- Allergia to melatonin
- Women
- Smoking.
- Alcohol abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: LPS + melatonin night
|
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
|
PLACEBO_COMPARATOR: LPS + placebo night
|
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
|
ACTIVE_COMPARATOR: LPS + melatonin day
|
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
|
PLACEBO_COMPARATOR: LPS + placebo day
|
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
|
EXPERIMENTAL: LPS night
|
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
|
EXPERIMENTAL: LPS day
|
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatoric markers
Time Frame: measured before and after the administration of LPS endotoxin.
|
IL-6 TNF-alpha YKL-40
|
measured before and after the administration of LPS endotoxin.
|
Oxidative markers
Time Frame: measured before and after the administration of LPS endotoxin.
|
Vit C MDA (malondialdehyde)
|
measured before and after the administration of LPS endotoxin.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary outcome
Time Frame: constant measurment
|
Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature
|
constant measurment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
January 1, 2011
Study Completion (ACTUAL)
February 1, 2011
Study Registration Dates
First Submitted
March 15, 2010
First Submitted That Met QC Criteria
March 15, 2010
First Posted (ESTIMATE)
March 16, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
June 20, 2011
Last Update Submitted That Met QC Criteria
June 17, 2011
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2-2010-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Human Endotoxaemia
-
AdventHealth Translational Research InstituteRecruitingHuman Body Composition | Human Body FunctionUnited States
-
University of AarhusAarhus University Hospital; University of Copenhagen; Arla FoodsActive, not recruitingBreast Milk Collection | Infant Gut Microbiome | Human Milk/Breastfeeding | Human Milk MicrobiomeDenmark
-
Universidade Federal do Rio de JaneiroCompleted
-
Integrative Skin Science and ResearchMicrobiome labsNot yet recruitingHuman MicrobiomeUnited States
-
DaniscoReprocell Inc; SerologixCompletedHuman MicrobiomeUnited States
-
Integrative Skin Science and ResearchSytheon Ltd.CompletedHuman MicrobiomeUnited States
-
The University of The West IndiesJ. Craig Venter InstituteCompletedHuman Microbiome
-
University of British ColumbiaMerck Canada Inc.CompletedHuman PapillomavirusCanada
-
Seoul National University HospitalCompletedHuman MicrobiomeKorea, Republic of
Clinical Trials on Melatonin
-
Duquesne UniversityCompleted
-
Peking Union Medical College HospitalCompleted
-
UnivatesAline Patrícia Brietzke; Ana Paula CostellaRecruitingPerimenopausal DisorderBrazil
-
Qazvin University Of Medical SciencesCompletedPost Partum Haemorrhage in Patients Undergoing Cesarean SectionIran, Islamic Republic of
-
Chinese PLA General HospitalUnknown
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Pharmavite LLCKGK Science Inc.Completed
-
Ain Shams UniversityCompletedCerebral Palsy | Growth | Children, Only | MelatoninEgypt
-
Mayo ClinicRecruitingParkinson Disease | Rapid Eye Movement Sleep Behavior DisorderUnited States
-
Providence Health & ServicesCompletedRelapsing Remitting Multiple SclerosisUnited States