Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-31 @ 6:48 PM
Study NCT ID:
NCT04645459
Status:
UNKNOWN
Last Update Posted:
2020-12-04
First Post:
2020-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Low Phosphorus 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', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anthropometric measurement', 'timeFrame': 'baseline', 'description': 'body height (cm)'}, {'measure': 'anthropometric measurement', 'timeFrame': 'one week after the washout period', 'description': 'body height (cm)'}, {'measure': 'anthropometric measurement', 'timeFrame': 'the end of the 7-days-study period', 'description': 'body height (cm)'}, {'measure': 'anthropometric measurement', 'timeFrame': 'baseline', 'description': 'body weight before hemodialysis (Kg), dry weight (Kg)'}, {'measure': 'anthropometric measurement', 'timeFrame': 'one week after the washout period', 'description': 'body weight before hemodialysis (Kg), dry weight (Kg)'}, {'measure': 'anthropometric measurement', 'timeFrame': 'the end of the 7-days-study period', 'description': 'body weight before hemodialysis (Kg), dry weight (Kg)'}, {'measure': 'blood pressure', 'timeFrame': 'baseline', 'description': 'systolic blood pressure (mmHg), diastolic blood pressure (mmHg)'}, {'measure': 'blood pressure', 'timeFrame': 'one week after the washout period', 'description': 'systolic blood pressure (mmHg), diastolic blood pressure (mmHg)'}, {'measure': 'blood pressure', 'timeFrame': 'the end of the 7-days-study period', 'description': 'systolic blood pressure (mmHg), diastolic blood pressure (mmHg)'}, {'measure': 'dietary contents', 'timeFrame': 'baseline', 'description': '24-hour dietary recall'}, {'measure': 'dietary contents', 'timeFrame': 'one week after the washout period', 'description': '24-hour dietary recall'}, {'measure': 'dietary contents', 'timeFrame': 'the end of the 7-days-study period', 'description': '24-hour dietary recall'}, {'measure': 'phosphate binder administration', 'timeFrame': 'baseline', 'description': 'type and dosing frequency'}, {'measure': 'phosphate binder administration', 'timeFrame': 'one week after the washout period', 'description': 'type and dosing frequency'}, {'measure': 'phosphate binder administration', 'timeFrame': 'the end of the 7-days-study period', 'description': 'type and dosing frequency'}, {'measure': 'indicators of dialysis adequacy', 'timeFrame': 'baseline', 'description': 'Kt/V'}, {'measure': 'indicators of dialysis adequacy', 'timeFrame': 'one week after the washout period', 'description': 'Kt/V'}, {'measure': 'indicators of dialysis adequacy', 'timeFrame': 'the end of the 7-days-study period', 'description': 'Kt/V'}, {'measure': 'blood lipid indicators', 'timeFrame': 'baseline', 'description': 'LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)'}, {'measure': 'blood lipid indicators', 'timeFrame': 'one week after the washout period', 'description': 'LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)'}, {'measure': 'blood lipid indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'normalized protein equivalent of total nitrogen appearance(g/kg/d)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'normalized protein equivalent of total nitrogen appearance(g/kg/d)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'normalized protein equivalent of total nitrogen appearance(g/kg/d)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'pre-Alb(mg/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'pre-Alb(mg/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'pre-Alb(mg/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'ferritin(ng/mL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'ferritin(ng/mL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'ferritin(ng/mL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'red blood cell (10\\^6/μL), white blood count(10\\^3/μL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'red blood cell (10\\^6/μL), white blood count(10\\^3/μL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'red blood cell (10\\^6/μL), white blood count(10\\^3/μL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'Hb (g/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'Hb (g/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'Hb (g/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'Hct (%)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'Hct (%)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'Hct (%)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'FGF23'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'FGF23'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'FGF23'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'iPTH (pg/mL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'iPTH (pg/mL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'iPTH (pg/mL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)'}, {'measure': 'biochemical indicators', 'timeFrame': 'baseline', 'description': 'estimated glomerular filtration rate (ml/min/1.73m\\^2)'}, {'measure': 'biochemical indicators', 'timeFrame': 'one week after the washout period', 'description': 'estimated glomerular filtration rate (ml/min/1.73m\\^2)'}, {'measure': 'biochemical indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'estimated glomerular filtration rate (ml/min/1.73m\\^2)'}, {'measure': 'inflammation indicators', 'timeFrame': 'baseline', 'description': 'C reactive protein (mg/dL)'}, {'measure': 'inflammation indicators', 'timeFrame': 'one week after the washout period', 'description': 'C reactive protein (mg/dL)'}, {'measure': 'inflammation indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'C reactive protein (mg/dL)'}, {'measure': 'inflammation indicators', 'timeFrame': 'baseline', 'description': 'interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)'}, {'measure': 'inflammation indicators', 'timeFrame': 'one week after the washout period', 'description': 'interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)'}, {'measure': 'inflammation indicators', 'timeFrame': 'the end of the 7-days-study period', 'description': 'interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)'}, {'measure': 'Electrolyte', 'timeFrame': 'baseline', 'description': 'P(mg/dL), Ca(mg/dL), Mg(mg/dL)'}, {'measure': 'Electrolyte', 'timeFrame': 'one week after the washout period', 'description': 'P(mg/dL), Ca(mg/dL), Mg(mg/dL)'}, {'measure': 'Electrolyte', 'timeFrame': 'the end of the 7-days-study period', 'description': 'P(mg/dL), Ca(mg/dL), Mg(mg/dL)'}, {'measure': 'Electrolyte', 'timeFrame': 'baseline', 'description': 'K(mEq/L), Na(mEq/L)'}, {'measure': 'Electrolyte', 'timeFrame': 'one week after the washout period', 'description': 'K(mEq/L), Na(mEq/L)'}, {'measure': 'Electrolyte', 'timeFrame': 'the end of the 7-days-study period', 'description': 'K(mEq/L), Na(mEq/L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis Patients']}, 'descriptionModule': {'briefSummary': "Consuming high levels of dietary phosphate and poor adherence of phosphate-binding-therapy might induce hyperphosphatemia in the hemodialysis (HD) patients. Therefore, the risks of Chronic Kidney Disease-related Mineral and Bone Disorders (CKD-MBDs) and inflammation will be increased. This double blind and intervention randomized controlled trial study will be designed to investigate the hypothesis that if low phosphorus meals decrease serum phosphorus concentration and inflammatory indicators. A total of 80 HD patients in the HD center of Shuang Ho Hospital will be recruited and be assigned to low phosphorus meal group (LP group) and control group randomly before one-week-washout period. The subjects of LP group and control group will consume low phosphorus meals and standard meals respectively. During washout period and study period, all subjects will continue to consume their regular breakfast and take one tablet of calcium carbonate with meal. All data will be collected at baseline, one week after the washout period, and the end of the 7-days-study period. The indicators are including dietary contents, phosphate binder administration, indicators of dialysis adequacy, nutritional indicators, blood lipid indicators, biochemical indicators, CKD-MBDs indicators, and inflammation indicators. Data were analyzed by Statistical Product and Service Solutions program version 18. Paired t-test, Student's t-test, Pearson correlation coefficient and Logistic regression will be used. P \\< 0.05 will be considered as statistically significant.", 'detailedDescription': 'Study Design and Subjects:\n\nThis study was design as a randomized, double-blind control trail. A total of 80 HD patients were recruited from the HD center of Taipei Medical University-Shuang Ho Hospital in Taiwan. The inclusion criteria were including ≧20 years old and non vegetarian. The exclusion criteria are including liver dysfunction, cancer and pregnancy.\n\nDietary Intervention:\n\nAll subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.\n\nFor controlling the volumes of proteins, phosphorus and calcium easily, the main courses of both of the study and the control meals were made by a central kitchen. All of the meals contained 3 exchanges of protein (25 g) and 1 exchange of vegetable. There were 5 main courses for the both diets. The proteins of the study meals had been removed by an average 20 -30% of the phosphorus through boiling the meats before cooking process. But the boiling method did not process for the control meals. Every meal including all the study and the control meals contained one tablet of calcium carbonate. As a consequence, the additional phosphate binders should not be taken while eating the study meals. The subjects had to prepare carbohydrate by themselves, and they could choose any source of carbohydrate as their wants.\n\nData Collection:\n\nThe personal characteristics and the anthropometry data were collected at baseline. All data were collected at baseline, one week after the washout period, and the end of the 7-days-study period. The indicators were including dietary contents, phosphate binder administration, dialysis adequacy, nutritional indicators, blood lipid indicators, biochemical indicators, CKD-MBDs indicators, and inflammation indicators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemodialysis patients, ≥ 20 years of age\n\nExclusion Criteria:\n\n* ≥ 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian'}, 'identificationModule': {'nctId': 'NCT04645459', 'briefTitle': 'The Influence of Low Phosphorus in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'The Influence of Low Phosphorus Meals on Serum Phosphorus Concentration and Inflammatory Indicators in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'N202004062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low phosphorus meal group (LP group)', 'description': 'The proteins of the low phosphorus meal had been removed by an average 20 -30% of the phosphorus through boiling the meats before cooking process.', 'interventionNames': ['Other: low phosphorus meals']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'The boiling method did not process for the control meals.', 'interventionNames': ['Other: control meals']}], 'interventions': [{'name': 'low phosphorus meals', 'type': 'OTHER', 'description': 'All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.', 'armGroupLabels': ['low phosphorus meal group (LP group)']}, {'name': 'control meals', 'type': 'OTHER', 'description': 'All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Mai-Szu Wu', 'role': 'CONTACT', 'email': 'maiszuwu@tmu.edu.tw', 'phone': '+886(2)28837300'}], 'facility': 'Shuang Ho Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Barbara Y.J. Chen', 'role': 'CONTACT', 'email': 'd507103001@tmu.edu.tw', 'phone': '+886963358528'}], 'overallOfficials': [{'name': 'Mai-Szu Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University Shuang Ho Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}