Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT01087359
Status:
COMPLETED
Last Update Posted:
2011-06-20
First Post:
2010-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-17', 'studyFirstSubmitDate': '2010-03-15', 'studyFirstSubmitQcDate': '2010-03-15', 'lastUpdatePostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatoric markers', 'timeFrame': 'measured before and after the administration of LPS endotoxin.', 'description': 'IL-6 TNF-alpha YKL-40'}, {'measure': 'Oxidative markers', 'timeFrame': 'measured before and after the administration of LPS endotoxin.', 'description': 'Vit C MDA (malondialdehyde)'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome', 'timeFrame': 'constant measurment', 'description': 'Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Human Endotoxaemia']}, 'descriptionModule': {'briefSummary': 'This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days:\n\n* day 1: On day time administration of LPS.\n* day 2: On night time administration of LPS.\n* day 3: On day time administration of LPS + Placebo.\n* day 4: On day time administration of LPS + melatonin.\n* day 5: On night time administration of LPS + placebo.\n* day 6: On night time administration og LPS + melatonin.\n\nMeasuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men\n* Age 18-49 year.\n* Healthy\n* No sleepiness disorders.\n* No medication\n* ASA I\n\nExclusion Criteria:\n\n* Allergia to melatonin\n* Women\n* Smoking.\n* Alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT01087359', 'briefTitle': 'Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia', 'orgStudyIdInfo': {'id': 'H-2-2010-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LPS + melatonin night', 'interventionNames': ['Drug: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LPS + placebo night', 'interventionNames': ['Drug: Melatonin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LPS + melatonin day', 'interventionNames': ['Drug: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LPS + placebo day', 'interventionNames': ['Drug: Melatonin']}, {'type': 'EXPERIMENTAL', 'label': 'LPS night', 'interventionNames': ['Drug: Melatonin']}, {'type': 'EXPERIMENTAL', 'label': 'LPS day', 'interventionNames': ['Drug: Melatonin']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'description': '100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo', 'armGroupLabels': ['LPS + melatonin day', 'LPS + melatonin night', 'LPS + placebo day', 'LPS + placebo night', 'LPS day', 'LPS night']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mahdi Alamili', 'oldOrganization': 'MA'}}}}