Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04077918
Status:
UNKNOWN
Last Update Posted:
2019-09-06
First Post:
2019-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Different Protein Diet in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2019-08-24', 'studyFirstSubmitQcDate': '2019-09-01', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Statistical difference of admissions', 'timeFrame': '7 months', 'description': ". We will also review the patient's admission record to see what's the diagnosis and what's the number of admission during the study period."}], 'primaryOutcomes': [{'measure': 'Statistical difference of serum biomarkers ( P value)', 'timeFrame': '7 months', 'description': "The items scheduled to be evaluated in this study include serum albumin, pre-albumin, phosphate, calcium, magnesium, lipid profile, ferritin, transferrin, hs-CRP, Alk-P, iPTH, 25(OH)D3, intact \\& C-terminal FGF23, Klotho and hepcidin levels. We'll collect the patient's serum data in plant diet group, and collect the serum data in animal diet group, then we'll compare the data in these two groups to see whether there is any difference between each item."}], 'secondaryOutcomes': [{'measure': 'Statistical difference of medical visits', 'timeFrame': '7 months', 'description': "We'll review the patient's medical record in outpatient department . We'll look at what's the diagnosis and what's the number of the medical visits during the study period."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffenence of Protein Diets on Hemodialysis Patients']}, 'descriptionModule': {'briefSummary': 'Chronic hemodialysis (CHD) patients are vulnerable to develop protein energy malnutrition and make a notion that to maintain the nutritional status is of paramount importance in these patients. However, proteins intake from vegetarian and meat diet were observed to have different impacts on nutritional and inflammatory status, mineral homeostasis and its related hormones, and clinical outcomes in non-dialysis CKD patients. In here, we aim to investigate these impacts in CHD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hemodialysis patient\n\nExclusion Criteria:\n\n1. Hemodialysis less than 3 months\n2. Age \\< 20 years or \\>90 years\n3. Serum albumin \\< 3 g/dL，\n4. Daily protein diet \\< 0.6 gm/kg/day or \\> 1.2 gm/kg/ day，\n5. Cannot obey the diet plan: Gastrectomy, difficult in swallowing\n6. Active infection, severe illness: cancer patient, liver cirrhosis, etc.\n7. Unable to cooperate in the study'}, 'identificationModule': {'nctId': 'NCT04077918', 'briefTitle': 'Comparison of the Effects of Different Protein Diet in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': "Camillians Saint Mary's Hospital Luodong"}, 'officialTitle': 'Comparison of the Effects of Animal Protein Diet and Plant Protein Diet on Blood Test Result and Clinical Outcome in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'SMHprotdiet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plant protein diet', 'description': '18 g of plant protein diet added every day for 3 months , and after washout for 1 month, 18 g of animal protein diet added every day for 3 months', 'interventionNames': ['Dietary Supplement: protein diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Animal protein diet', 'description': '18 g of animal protein diet added every day for 3 months, and after washout for 1 month, 18 g of plant protein diet added every day for 3 months', 'interventionNames': ['Dietary Supplement: protein diet']}], 'interventions': [{'name': 'protein diet', 'type': 'DIETARY_SUPPLEMENT', 'description': '100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day', 'armGroupLabels': ['Animal protein diet', 'Plant protein diet']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shih-Ching Tsai, MD', 'role': 'CONTACT', 'email': 'uftsai.tseng@msa.hinet.net', 'phone': '+88639544106', 'phoneExt': '7951'}, {'name': 'Yu-Ming Chang, MD', 'role': 'CONTACT', 'email': 'ynk123.tw@yahoo.com.tw', 'phone': '+88639544106', 'phoneExt': '7952'}], 'overallOfficials': [{'name': 'Shih-Ching Tsai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Mary's Hospital Luodong"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Camillians Saint Mary's Hospital Luodong", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}