Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-02-20 @ 9:11 PM
Study NCT ID:
NCT00388661
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2006-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin and Quality of Life in Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2006-10-16', 'studyFirstSubmitQcDate': '2006-10-16', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)', 'timeFrame': '6-12 months'}, {'measure': 'Improvement general health by 15 points (dimension quality of life, RAND SF 36)', 'timeFrame': '6-12 months'}], 'secondaryOutcomes': [{'measure': 'Change in biochemical parameters', 'timeFrame': '3-6-9-12 months'}, {'measure': 'Change in ProBNP', 'timeFrame': '12 months'}, {'measure': 'Change in nutritional status', 'timeFrame': '12 months'}, {'measure': 'Change in use of medication', 'timeFrame': '6-12 months'}, {'measure': 'Change in preload', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep problems', 'quality of life', 'melatonin', 'sleep apnea', 'medication', 'preload', 'nutritional status', 'ProBNP'], 'conditions': ['Sleep Problems', 'Haemodialysis']}, 'descriptionModule': {'briefSummary': 'Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulation of these circadian rhythms a uniform external synchronisation is necessary. This is the synchronisation of the biological clock of our body by light and other influences. In case of a disturbance of the external synchronisation, due to for example naps during the day or wake periods at night, internal rhythms can be unlinked. As a result a weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis patients have sleep problems. Their sleep latency is prolonged. They often take a nap during the day and their sleep efficiency is poor. There has only been one study on the melatonin rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this study no link was made between melatonin rhythm and the nature and severity of possible sleep problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm, exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal biological clock and a better quality of life.\n\nThe aim is to improve quality of life of hemodialysis patients with a placebo-controlled study with melatonin to investigate if exogenous melatonin can improve sleep problems and on the longer term improve quality of life (and secondary morbidity) of dialysis patients.', 'detailedDescription': 'Objective of the study:\n\nDoes melatonin by improving sleep parameters improve quality of life of hemodialysis patients?\n\nStudy design:\n\nPlacebo-controlled, double-blind, randomized trial\n\nStudy population:\n\nhemodialysis patients\n\nIntervention:\n\nmelatonin 3 mg once daily (or placebo)\n\nPrimary study parameters/outcome of the study:\n\n1. improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)\n2. improvement general health by 15 points (dimension quality of life, RAND SF 36)\n\nSecondary study parameters/outcome of the study:\n\n1. Change in biochemical parameters\n2. Change in ProBNP\n3. Change in nutritional status\n4. Change in use of medication\n5. Change in preload'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed Consent\n* Man/Women between 18 and 85 years\n* Understanding and knowledge of the dutch language\n* End Stage Renal Disease, stable chronic hemodialysis \\> 3 months\n* SpKt/V(total) \\> 1,2 pro dialysis\n* Validated actometer shows that sleep efficiency \\< 90% or sleep latency \\> 15 minutes or fragmentation index \\> 25 points\n\nExclusion Criteria:\n\n* Known major illness, which interferes with patient's participation in the study according to the investigator)or which results in a probable patient's survival of less than 1 year.\n* Instable angina pectoris, heart failure NYHA class IV\n* Pregnancy\n* Current use of melatonin of known allergy of melatonin\n* Participation in other medication/drug research within a month before inclusion"}, 'identificationModule': {'nctId': 'NCT00388661', 'briefTitle': 'Melatonin and Quality of Life in Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Meander Medical Center'}, 'officialTitle': 'Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'R-06.31 M / Melody'}, 'secondaryIdInfos': [{'id': 'R-06.31 M'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin', 'description': 'melatonin 3mg', 'interventionNames': ['Drug: Melatonin tablet 3 mg once daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo comparator']}], 'interventions': [{'name': 'Melatonin tablet 3 mg once daily', 'type': 'DRUG', 'description': 'Melatonin tablet 3 mg once daily', 'armGroupLabels': ['Melatonin']}, {'name': 'Placebo comparator', 'type': 'DRUG', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3800 BM', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medical Center', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '2035 RC', 'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}], 'overallOfficials': [{'name': 'Pieter ter Wee, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meander Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Kidney Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Department of Clinical Pharmacy', 'oldOrganization': 'Meander Medical Center'}}}}