Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-04 @ 5:39 PM
Study NCT ID:
NCT04185168
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2019-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isoflavones and Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D030262', 'term': 'Soybean Proteins'}], 'ancestors': [{'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2019-12-01', 'studyFirstSubmitQcDate': '2019-12-01', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glucose', 'timeFrame': '8 weeks', 'description': 'Serum concentrations of glucose'}, {'measure': 'fructoseamine', 'timeFrame': '8 weeks', 'description': 'Serum concentrations of fructoseamine'}, {'measure': 'carboxymethyl lysine', 'timeFrame': '8 weeks', 'description': 'Serum concentrations of carboxymethyl lysine'}, {'measure': 'pentosidine', 'timeFrame': '8 weeks', 'description': 'Serum concentrations of pentosidine'}, {'measure': 'Systolic blood pressure', 'timeFrame': '8 weeks', 'description': 'Systolic blood pressure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '8 weeks', 'description': 'Diastolic blood pressure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peritoneal Dialysis']}, 'descriptionModule': {'briefSummary': 'The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of fructoseamine, carboxymethyl lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nContinuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35\n\nExclusion Criteria:\n\ninfections inflammatory diseases liver diseases Clinical diagnosis of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet'}, 'identificationModule': {'nctId': 'NCT04185168', 'briefTitle': 'Isoflavones and Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'Effects of Isoflavones on Hypertension, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': '250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'isoflavone', 'description': '100 mg soy isoflavone (as 2 tablets)', 'interventionNames': ['Dietary Supplement: soy isoflavone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': '2 tablets of placebo', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'soy isoflavone', 'type': 'DIETARY_SUPPLEMENT', 'description': '100 mg soy isoflavone (as 2 tablets)', 'armGroupLabels': ['isoflavone']}, {'name': 'control', 'type': 'OTHER', 'description': '2 tablets of placebo', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1981619573', 'city': 'Tehran', 'state': 'Iran (the Islamic Republic Of)', 'country': 'Iran', 'facility': 'National Nutrition and Food Technology Research Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'zahra yari', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}