Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT00702312
Status:
COMPLETED
Last Update Posted:
2009-07-29
First Post:
2008-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Bengali Dietary Salt Study to Control Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-28', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in blood pressure', 'timeFrame': 'Six months'}], 'secondaryOutcomes': [{'measure': 'Reduction in dietary salt intake', 'timeFrame': 'Six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blood pressure'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '34164803', 'type': 'DERIVED', 'citation': 'McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.'}, {'pmid': '23766446', 'type': 'DERIVED', 'citation': 'de Brito-Ashurst I, Perry L, Sanders TA, Thomas JE, Dobbie H, Varagunam M, Yaqoob MM. The role of salt intake and salt sensitivity in the management of hypertension in South Asian people with chronic kidney disease: a randomised controlled trial. Heart. 2013 Sep;99(17):1256-60. doi: 10.1136/heartjnl-2013-303688. Epub 2013 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the benefits of using low-salt and healthy eating educational programme, designed specifically for Bangladeshi kidney patients, compared to the usual diet advice given by the clinic dietitians.', 'detailedDescription': 'We conducted an exploratory study initially to learn about the East London Bangladeshi (ELB) kidney patients salt intake. Furthermore, we assessed their educational needs to inform the development and implementation of an educational programme to reduce dietary salt intake in line with the Department of Health recommendations for a good blood pressure control. The educational programme will be tested in a randomized controlled trial. We are interested in salt because studies have shown that salt is one of the causes of high blood pressure. Scientific studies have also shown that the longer a person has high blood pressure the more the damage to the kidneys.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Bengali kidney disease hypertensive patients\n\nExclusion Criteria:\n\n* Non-hypertensive Bengali patients and those on dialysis therapy'}, 'identificationModule': {'nctId': 'NCT00702312', 'briefTitle': 'A Bengali Dietary Salt Study to Control Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'A Multi-method Study of a Low-salt Dietary Approach to Control Blood Pressure in the Bangladeshi Chronic Kidney Disease Population.', 'orgStudyIdInfo': {'id': '07/Q0605/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Study group that will attend low-salt educational community programme', 'interventionNames': ['Behavioral: Low-salt educational programme', 'Behavioral: Low-salt Bangladeshi educational programme']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Subjects in this arm will have routine medical and dietetic treatment for low-salt reduction.'}], 'interventions': [{'name': 'Low-salt educational programme', 'type': 'BEHAVIORAL', 'otherNames': ['Low-salt health education'], 'description': 'Subjects will attend a health promotion cooking programme and receive written tailored low-salt Bengali educational tool. This tool has been developed specifically for this population group from Phase 1 and 2 study.', 'armGroupLabels': ['Study group']}, {'name': 'Low-salt Bangladeshi educational programme', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention group'], 'description': 'A multi-component low-salt educational programme tailored to the Bangladeshi kidney disease patients delivered in the community.', 'armGroupLabels': ['Study group']}, {'name': 'Low-salt Bangladeshi educational programme', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention group/ Educational group / Low-salt group'], 'description': 'A multi-component Low-salt educational programme tailored to the Bangladeshi kidney disease patients residents in Tower Hamlets delivered over 5 months.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ione Ashurst, BSc, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts and The London NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': "St. Bartholomew's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ione Ashurst', 'oldOrganization': 'Barts and The London NHS Trust'}}}}