Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT04336566
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Effects of Melatonin Trial in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant, care provider, data manager/monitor, principle investigator all blinded'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Albuminuria', 'timeFrame': '6 months', 'description': 'protein in urine'}], 'secondaryOutcomes': [{'measure': 'Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire', 'timeFrame': '6 months', 'description': 'Scale 0-21, higher scores indicate worse sleep quality'}, {'measure': 'Sodium levels', 'timeFrame': '6 months', 'description': 'electrolyte in blood'}, {'measure': 'Urinalysis', 'timeFrame': '6 months', 'description': 'To asses electrolyte and protein levels'}, {'measure': 'Creatinine levels', 'timeFrame': '6 months', 'description': 'serum blood'}, {'measure': 'Blood Urea Nitrogen (BUN) levels', 'timeFrame': '6 months', 'description': 'Blood Urea Nitrogen'}, {'measure': 'Potassium levels', 'timeFrame': '6 months', 'description': 'mineral in blood'}, {'measure': 'Bicarbonate levels', 'timeFrame': '6 months', 'description': 'base found in blood'}, {'measure': 'Chloride levels', 'timeFrame': '6 months', 'description': 'electrolyte in blood'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.', 'detailedDescription': 'Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)\n* Random urine microalbumin of 30 mcg or greater (protein in the urine)\n* Have ability to complete a sleep survey\n* Currently not on melatonin therapy.\n\nExclusion Criteria:\n\n* End Stage Renal Disease\n* CKD Stage IV (stage 4 with severe kidney dysfunction)\n* Severe liver disease\n* Chronic dialysis therapy'}, 'identificationModule': {'nctId': 'NCT04336566', 'acronym': 'REM', 'briefTitle': 'Renal Effects of Melatonin Trial in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)', 'orgStudyIdInfo': {'id': '10584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin', 'description': '5mg dose of melatonin manufactured by Good Neighbor Pharmacy', 'interventionNames': ['Dietary Supplement: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Good Neighbor Pharmacy placebo tablet that looks the same without active ingredient', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Melatonin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Melatonin 5mg', 'armGroupLabels': ['Melatonin']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Comparable Good Neighbor Pharmacy placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma School of Community Medicine', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Krishna M Baradhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OUHSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}