Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-30 @ 3:52 PM
Study NCT ID:
NCT02525835
Status:
WITHDRAWN
Last Update Posted:
2018-09-25
First Post:
2015-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Sodium in Autoimmune Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sodium concentration in skin', 'timeFrame': '3 months', 'description': 'sodium concentration in skin after 1 month low salt diet will be compared to sodium concentration in skin after 1 month high sodium diet, with 2 week wash out between'}], 'secondaryOutcomes': [{'measure': 'SLEDAI', 'timeFrame': '3 months', 'description': "SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, a list of 24 items that covers clinical findings and laboratory tests that combined indicate how active a participant's disease is. SLEDAI after 1 month low salt diet will be compared to SLEDAI after 1 month high sodium diet, with 2 week wash out between"}, {'measure': 'blood pressure', 'timeFrame': '3 months', 'description': 'Blood pressure after 1 month low salt diet will be compared to blood pressure after 1 month high sodium diet, with 2 week wash out between'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'This pilot study will test the hypothesis that a low sodium diet will decrease sodium (23Na) magnetic resonance imaging-determined skin sodium concentrations in patients with systemic lupus erythematosus (SLE) and improve blood pressure and inflammation', 'detailedDescription': 'This pilot study will test the hypothesis that a low sodium diet will decrease 23Na magnetic resonance imaging-determined skin sodium concentrations in patients with SLE and improve blood pressure and inflammation. Investigators plan to enroll 21 participants who will be randomized to low salt or high salt diet. Participants will eat the first diet for 28 days, and after a 2 week washout, Participants will eat the second diet (whichever the participant was not randomized to for the first phase). Participant will know what diet participant is on, study coordinator who does the assessment will be blinded to diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female patients 18 and over\n* meets 2012 International criteria for the diagnosis of SLE\n* have stable disease activity as evidenced by no significant change in immunomodulating therapy in last month\n* provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Receiving dialysis\n* Organ or bone marrow transplant\n* Uncontrolled hypertension, BP\\> 160/100 mm Hg at screening\n* Severe edema as judged by investigator\n* Diabetes mellitus requiring drug therapy\n* Major surgery within the previous 3 months\n* Severe co-morbid conditions such as active cancer likely to compromise study participation\n* unwillingness or other inability to cooperate\n* Conditions that alter sodium homeostasis substantially including heart failure, clinically evident liver disease, clinically evident renal dysfunction (creatinine clearance \\< 50 nl/min or \\> 2+ proteinuria, or being treated for lupus nephritis'}, 'identificationModule': {'nctId': 'NCT02525835', 'briefTitle': 'Tissue Sodium in Autoimmune Disease', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Tissue Sodium in Autoimmune Disease', 'orgStudyIdInfo': {'id': '150713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dietary Sodium', 'description': 'Participants will be randomized to a low sodium diet (50 mmol/24 hours) for 28 days (range allowed 25-31 days) or a high sodium diet (250 mmol/24 hours) for 28 days (range allowed 25-31 days) with a 4 week washout period between (range 2-3 weeks).', 'interventionNames': ['Dietary Supplement: Low Dietary Sodium']}, {'type': 'EXPERIMENTAL', 'label': 'High Dietary Sodium', 'description': 'Participants will be randomized to a low sodium diet (50 mmol/24 hours) for 28 days (range allowed 25-31 days) or a high sodium diet (250 mmol/24 hours) for 28 days (range allowed 25-31 days) with a 4 week washout period between (range 2-3 weeks).', 'interventionNames': ['Dietary Supplement: High Dietary Sodium']}], 'interventions': [{'name': 'Low Dietary Sodium', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will be randomized to a low sodium diet (50 mmol/24 hours) for 28 days (range allowed 25-31 days) with a 4 week washout period between (range 2-3 weeks).', 'armGroupLabels': ['Low Dietary Sodium']}, {'name': 'High Dietary Sodium', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will be randomized to a high sodium diet (250 mmol/24 hours) for 28 days (range allowed 25-31 days) with a 4 week washout period between (range 2-3 weeks).', 'armGroupLabels': ['High Dietary Sodium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Charles M Stein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dan May Professor of Medicine and Pharmacology, Assc. Director Division of Clinical Pharmacology', 'investigatorFullName': 'C. Michael Stein', 'investigatorAffiliation': 'Vanderbilt University'}}}}