Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 8:27 AM
Study NCT ID:
NCT03966235
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2019-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin on Coronary Artery Calcification
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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2019-05-26', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a change in CAC score at 6 months measured by coronary CTA', 'timeFrame': 'at 6 months', 'description': 'The primary efficacy endpoint was the effect of melatonin on the change in CAC score at 6 months compared with placebo.'}], 'secondaryOutcomes': [{'measure': 'high-sensitivity C-reactive protein (hsCRP) level', 'timeFrame': 'at 6 months', 'description': 'a change in high-sensitivity C-reactive protein (hsCRP) level at 6 months after treatment.'}, {'measure': 'malondialdehyde (MDA) level', 'timeFrame': 'at 6 months', 'description': 'a change in malondialdehyde (MDA) level at 6 months after treatment.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melatonin', 'coronary artery calcification', 'adjuvant therapy'], 'conditions': ['Coronary Artery Calcification']}, 'referencesModule': {'references': [{'pmid': '30476723', 'type': 'BACKGROUND', 'citation': 'Gilham D, Tsujikawa LM, Sarsons CD, Halliday C, Wasiak S, Stotz SC, Jahagirdar R, Sweeney M, Johansson JO, Wong NCW, Kalantar-Zadeh K, Kulikowski E. Apabetalone downregulates factors and pathways associated with vascular calcification. Atherosclerosis. 2019 Jan;280:75-84. doi: 10.1016/j.atherosclerosis.2018.11.002. Epub 2018 Nov 14.'}, {'pmid': '28122774', 'type': 'BACKGROUND', 'citation': 'Shobeiri N, Bendeck MP. Interleukin-1beta Is a Key Biomarker and Mediator of Inflammatory Vascular Calcification. Arterioscler Thromb Vasc Biol. 2017 Feb;37(2):179-180. doi: 10.1161/ATVBAHA.116.308724. No abstract available.'}, {'pmid': '26201382', 'type': 'BACKGROUND', 'citation': 'Fernandez A, Ordonez R, Reiter RJ, Gonzalez-Gallego J, Mauriz JL. Melatonin and endoplasmic reticulum stress: relation to autophagy and apoptosis. J Pineal Res. 2015 Oct;59(3):292-307. doi: 10.1111/jpi.12264. Epub 2015 Aug 9.'}, {'pmid': '29203148', 'type': 'BACKGROUND', 'citation': 'Dehdashtian E, Mehrzadi S, Yousefi B, Hosseinzadeh A, Reiter RJ, Safa M, Ghaznavi H, Naseripour M. Diabetic retinopathy pathogenesis and the ameliorating effects of melatonin; involvement of autophagy, inflammation and oxidative stress. Life Sci. 2018 Jan 15;193:20-33. doi: 10.1016/j.lfs.2017.12.001. Epub 2017 Dec 5.'}, {'pmid': '26681403', 'type': 'RESULT', 'citation': 'Wang Z, Ni L, Wang J, Lu C, Ren M, Han W, Liu C. The protective effect of melatonin on smoke-induced vascular injury in rats and humans: a randomized controlled trial. J Pineal Res. 2016 Mar;60(2):217-27. doi: 10.1111/jpi.12305. Epub 2016 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis.', 'detailedDescription': 'CAC is prevalent in coronary artery disease (CHD), and the extent of CAC predicts cardiovascular risk. The causes of CAC include dysregulated matrix metabolism, epitaxial mineral deposition, inflammation, oxidative stress, and apoptosis. Melatonin is the main indoleamine produced by the pineal gland; it is known recently to have anti-inflammatory, anti-cancer and antioxidant activities. Several studies have shown that melatonin protects against inflammation and apoptosis in vascular calcification. Melatonin also inhibits oxidative stress-induced apoptosis and calcification in endplate chondrocytes. The investigators planned to determine the efficacy of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis. This study may shed light as to whether oral melatonin supplementation can be an adjunct therapy in CAC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with a documented Agatston scoreā„30 and moderate calcified coronary atherosclerosis (\\<50% diameter lumen narrowing) were eligible for the study.\n\nExclusion Criteria:\n\n1. unstable angina pectoris\n2. symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) \\<40%\n3. atrial fibrillation or other arrhythmias\n4. type I diabetes mellitus or uncontrolled type II diabetes mellitus\n5. renal failure\n6. liver disease\n7. gastrointestinal disease that affected absorption'}, 'identificationModule': {'nctId': 'NCT03966235', 'acronym': 'MelonCAC', 'briefTitle': 'Melatonin on Coronary Artery Calcification', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Effects of Melatonin on Progression of Coronary Artery Calcification', 'orgStudyIdInfo': {'id': 'MelonCAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melatonin group', 'description': 'drug: melatonin tablets (Sigma-Aldrich Co. LLC, St. Louis, MO, USA); the frequency:3mg melatonin tablet was taken daily; duration: study treatment was maintained for 6 months.', 'interventionNames': ['Drug: Melatonin 3 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Melatonin 3 mg', 'type': 'DRUG', 'otherNames': ['melatonin'], 'description': 'Melatonin was taken daily for 6 months.', 'armGroupLabels': ['Melatonin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet was taken daily for 6 months.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wei ren chen', 'role': 'CONTACT'}], 'facility': 'PLA general hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'wei ren chen, MD', 'role': 'CONTACT', 'email': 'chen_weiren@sina.com', 'phone': '+8601066876231'}], 'overallOfficials': [{'name': 'yu jie zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Chen Wei Ren, MD', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}