Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05469620
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2022-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptive Nutrition Therapy in Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062407', 'term': 'Meals'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '2 by 2 factorial design, consisting of nutrition education and meal kit prescription.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2022-07-20', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potassium', 'timeFrame': '4 weeks', 'description': 'Serum potassium level measured from routine blood test.'}, {'measure': 'Phosphate', 'timeFrame': '4 weeks', 'description': 'Serum phosphate level measured from routine blood test.'}, {'measure': 'Malnutrition', 'timeFrame': '8 weeks', 'description': '10-item nutritional status measured with Malnutrition Inflammation Score. Scores range from 0 to 30, higher value corresponding to worse outcome (higher risk of malnutrition)'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': '8 weeks', 'description': '21-item depression score measured with Korean-Beck Depression Inventory. Scores rnage from 0 to 63, higher value corresponding to worse outcome (severe depression).'}, {'measure': 'Self-Efficacy', 'timeFrame': '8 weeks', 'description': '10-item Self-Efficacy score for hemodialysis patients. Scores range from 10 to 40, higher values corresponding to better outcome (higher self-efficacy).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrition'], 'conditions': ['Renal Dialysis']}, 'descriptionModule': {'briefSummary': '8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have been on hemodialysis for over 3 months\n\nExclusion Criteria:\n\n* diagnosed with cancer within 5 years'}, 'identificationModule': {'nctId': 'NCT05469620', 'briefTitle': 'Adaptive Nutrition Therapy in Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of Adaptive Nutrition Therapy in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'DNET_CKD nutrition 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Receive usual care.'}, {'type': 'EXPERIMENTAL', 'label': 'Education', 'description': 'Receive nutrition education.', 'interventionNames': ['Other: Education']}, {'type': 'EXPERIMENTAL', 'label': 'Meal', 'description': 'Receive meal kit.', 'interventionNames': ['Dietary Supplement: Meal']}, {'type': 'EXPERIMENTAL', 'label': 'Education and Meal', 'description': 'Receive both nutrition education and meal kit.', 'interventionNames': ['Dietary Supplement: Meal', 'Other: Education']}], 'interventions': [{'name': 'Meal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Either a meal kit low in sodium, potassium, and phosphorus; or a meal kit low in sodium only is provided based on predefined logic. Meal kits are delivered in bulk twice a week, meant to replace one meal a day.', 'armGroupLabels': ['Education and Meal', 'Meal']}, {'name': 'Education', 'type': 'OTHER', 'description': 'Leaflet or video education materials on seven nutrition-related topics are provided, based on predefined logic. Materials are sent throughout the week, via SMS links.', 'armGroupLabels': ['Education', 'Education and Meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100-032', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Inje University Seoul Paik Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hallym University Kangnam Sacred Heart Hospital', 'class': 'OTHER'}, {'name': 'KangWon National University Hospital', 'class': 'OTHER'}, {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, {'name': 'Korea University Ansan Hospital', 'class': 'OTHER'}, {'name': 'Myongji Hospital', 'class': 'OTHER'}, {'name': 'Korea Data Agency', 'class': 'UNKNOWN'}, {'name': 'Eatmapl', 'class': 'UNKNOWN'}, {'name': 'Daejeon Eulji Medical Center', 'class': 'UNKNOWN'}, {'name': 'Seoul National University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Hoseok Koo', 'investigatorAffiliation': 'Inje University'}}}}