Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT01846234
Status:
COMPLETED
Last Update Posted:
2013-10-22
First Post:
2013-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Intake in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-21', 'studyFirstSubmitDate': '2013-05-01', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exacerbation rate', 'timeFrame': '2 years', 'description': 'Number of disease relapses during follow up time according to salt consumption'}], 'secondaryOutcomes': [{'measure': 'Radiological activity', 'timeFrame': 'One year', 'description': 'Number of new lesions in MRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Salt'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Recently, it has been shown that salt (ClNa, sodium chloride) can modulate the differentiation of human and mouse TH17 cells. Indeed, mice feed with high sodium diet were described to develop more aggressive course of EAE (Experimental Autoimmune Encephalitis).\n\nHowever, the role of sodium intake in MS has not been investigated. In this study we investigate the effect of sodium intake in Multiple Sclerosis (MS) clinical and radiological activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 70 patients with relapsing-remitting MS according to McDonald criteria1 were recruited from the MS clinic at FLENI by attending neurologists. A second group of 52 relapsing-remitting MS patients was recluted later.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is between 18 and 50 years old\n* Subject has diagnosis of relapsing-remitting MS according to McDonald criteria (2010)\n\nExclusion Criteria:\n\n* Patient who had hyponatremia in the last 90 days'}, 'identificationModule': {'nctId': 'NCT01846234', 'acronym': 'SALT', 'briefTitle': 'Sodium Intake in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia'}, 'officialTitle': 'Effect of Sodium Intake in Multiple Sclerosis Disease Activity', 'orgStudyIdInfo': {'id': 'Salt'}, 'secondaryIdInfos': [{'id': 'Salt-1', 'type': 'OTHER_GRANT', 'domain': 'FLENI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'MS patients', 'description': 'MS patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1428', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'FLENI', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Mauricio F Farez, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Mauricio F. Farez', 'investigatorAffiliation': 'Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia'}}}}