Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-03 @ 6:46 AM
Study NCT ID:
NCT01762267
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2012-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of DASH Diet on Corticosteroids Medication Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-04', 'studyFirstSubmitDate': '2012-12-01', 'studyFirstSubmitQcDate': '2013-01-04', 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'lipid profile (mg/dl), fasting blood glucose (mg/dl), blood pressure (mmHg), weight reduction (kg)', 'timeFrame': 'july'}], 'primaryOutcomes': [{'measure': 'the amount of weight reduction and change of blood pressure', 'timeFrame': 'up to 10 weeks', 'description': 'weight (kg) body mass index (kg/m2) blood pressure (mmHg)'}], 'secondaryOutcomes': [{'measure': 'lipid profile, fasting blood glucose', 'timeFrame': '10 weeks', 'description': 'measurement of LDL-C (mg/dl), HDL-C (mg/dl), triglyceride (mg/dl), total cholesterol (mg/dl), fasting blood glucose(mg/dl), by the analysis of blood samples and blood pressure(mmHg) and weight (kg), waist circumference (cm), body mass index (kg/m2).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nutritional and Metabolic Disease']}, 'descriptionModule': {'briefSummary': 'To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.', 'detailedDescription': 'Objective: To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.\n\nDesign: A randomized clinical trial was undertaken in 60 patients on corticosteroid therapy for 10 weeks. Patients were randomly assigned to a DASH or control diet. Fasting blood sample were measured to determine blood glucose and lipid profile. Blood pressure and anthropometric measurements were measured based on the standard guidelines.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '27 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who were on corticosteroid therapy\n\nExclusion Criteria:\n\n* refuse to follow the visits'}, 'identificationModule': {'nctId': 'NCT01762267', 'briefTitle': 'Effects of DASH Diet on Corticosteroids Medication Use', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Phase 3 Study of Beneficiary Effects of Dietary Approaches to Stop Hypertension (DASH) on the Metabolic Aeffects of Corticosteroids Medications Use', 'orgStudyIdInfo': {'id': 'DASH in corton therapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'diet intervention, DASH diet', 'description': 'intervention: nutrition intervention: DASH diet', 'interventionNames': ['Other: nutrition intervention']}, {'type': 'NO_INTERVENTION', 'label': 'not intervention, control diet', 'description': 'control weight loss diet'}], 'interventions': [{'name': 'nutrition intervention', 'type': 'OTHER', 'description': 'DASH diet control diet', 'armGroupLabels': ['diet intervention, DASH diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'country': 'Iran', 'facility': '1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'Leila azadbakht, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': '1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Isfahan University of Medical Sciences', 'investigatorFullName': 'Leila Azadbakht', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}