Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
Study NCT ID:
NCT04413266
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2020-05-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis
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': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antioxidants and anti-inflammatory biomarkers', 'timeFrame': '4 weeks', 'description': 'Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathione peroxidase (GPx), heme oxygenase-1 (HO-1)'}, {'measure': 'Inflammatory biomarkers', 'timeFrame': '4 weeks', 'description': 'Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappaB, interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), PCR, IL-18, TBARS, Inflammasome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'peritoneal dialysis', 'curcumin', 'hemodialysis'], 'conditions': ['Chronic Kidney Diseases', 'Peritoneal Dialysis', 'Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '38220413', 'type': 'DERIVED', 'citation': 'Reis DCMV, Alvarenga L, Cardozo LFMF, Baptista BG, Fanton S, Paiva BR, Ribeiro-Alves M, Fortunato RS, Vasconcelos AL, Nakao LS, Sanz CL, Berretta AA, Leite M Jr, Mafra D. Can curcumin supplementation break the vicious cycle of inflammation, oxidative stress, and uremia in patients undergoing peritoneal dialysis? Clin Nutr ESPEN. 2024 Feb;59:96-106. doi: 10.1016/j.clnesp.2023.11.015. Epub 2023 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess whether supplementation with curcumin could modulate the intestinal microbiota, reducing levels of inflammatory markers of oxidative stress, uremic toxins and inflammasome, in patients with chronic kidney disease in peritoneal dialysis.', 'detailedDescription': 'Curcumin is a chemical compound of the curcuminoids class found in the root of Curcuma (Curcuma longa), and due to its potential antioxidant and anti-inflammatory, has been suggested as a nutritional strategy to reduce oxidative stress and inflammation present in several chronic diseases. Although it is a promising therapy, there are no studies evaluating the effects of curcumin in patients with chronic kidney disease (CKD) in peritoneal dialysis (PD). The aim of this study is to evaluate the effect of curcumin supplementation on inflammatory markers and oxidative stress in patients with CKD in PD. Methods: This is a longitudinal randomized clinical double-blind crossover study, with a washout period and placebo-controlled, where patients will be randomized into two groups: Turmeric and Placebo. After the 12-week supplementation period, a washout (12 weeks) will be performed for subsequent crossover of the patients. Mononuclear cells will be extracted from whole blood and the expression of m ribonucleic acid from transcription factors (Nrf2 and NF-kB), antioxidant enzymes (NQO1, HO-1), as well as NLRP3 inflammasome will be analyzed by real-time Polymerase Chain Reaction and protein expression by western blotting. Inflammatory cytokine levels will be assessed by ELISA, also, plasma levels of TBARS, routine laboratory parameters, as well as food intake and nutritional status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Chronic Kidney Disease\n* Peritoneal dialysis patients for more than 6 months\n* Aged from 18 to 60 years\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* Patients pregnant\n* Smokers\n* Using antibiotics in the last 3 months\n* Using antioxidant supplements in the last 3 months\n* Usual intake of turmeric\n* Usual intake Autoimmune\n* Clinical diagnosis of infectious diseases\n* Clinical diagnosis of Cancer\n* Clinical diagnosis of AIDS'}, 'identificationModule': {'nctId': 'NCT04413266', 'briefTitle': 'Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal Fluminense'}, 'officialTitle': 'Effects of Curcumin Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease on Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'Denise Mafra7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Curcumin for CKD', 'description': 'Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks', 'interventionNames': ['Dietary Supplement: Curcumin supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for CKD', 'description': 'Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks', 'interventionNames': ['Dietary Supplement: Curcumin supplementation']}], 'interventions': [{'name': 'Curcumin supplementation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Dietary Supplement', 'Placebo'], 'description': 'The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks', 'armGroupLabels': ['Curcumin for CKD', 'Placebo for CKD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22260050', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Denise Mafra', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Denise Mafra, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University Fluminense'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal Fluminense', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}