Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 2:26 AM
Study NCT ID:
NCT04600193
Status:
UNKNOWN
Last Update Posted:
2021-03-18
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2020-10-19', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma levels of phosphate', 'timeFrame': 'six days'}], 'secondaryOutcomes': [{'measure': 'Changes in p-phosphate', 'timeFrame': 'six days'}, {'measure': 'changes in p-calcium', 'timeFrame': 'six days'}, {'measure': 'Changes in p-sodium', 'timeFrame': 'six days'}, {'measure': 'Changes in p-potassium', 'timeFrame': 'six days'}, {'measure': 'changes in p-PTH', 'timeFrame': 'six days'}, {'measure': 'Changes in p-FGF23', 'timeFrame': 'six days'}, {'measure': 'Changes in p-magnesium', 'timeFrame': 'six days'}, {'measure': 'Koncentration of phosphate in peritoneal dialysis fluid', 'timeFrame': 'six days'}, {'measure': 'Koncentration of phosphate in urine', 'timeFrame': 'six days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease Requiring Chronic Dialysis']}, 'descriptionModule': {'briefSummary': 'Hyperphosphatemia is a common problem among patientens suffering from chronic kidney disease. Hyperphosphatemia is associated with increased risk of cardiovascular diseases. One of the treatments are through the diet, where patients are instructed ind reducing their daily intake of phosphate. But since phosphate exists in both organic and inorganic forms in the diet, this leads to several problems. Informations of the bioavability and furthermore the effect of plasma koncentrations of phosphate are lacking for both forms of phosphate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years\n* Competent\n* The patient should be able to take a sample of p-fluid and urine by himself\n* Chronic peritoneal dialysis\n* Reads and understand danish\n* Has been informed written and oraly about the study and signed informed consent\n* P-phosphate koncentrations 0,7-2,0 .mol/l\n* P - ioniset calcium 1,1-1,4 mmol/l\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding\n* Terminal patients\n* If the experience acute infections or other acute situations they will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT04600193', 'acronym': 'RCTOIP', 'briefTitle': 'a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': 'IOOAIOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phosphate modified diet with organic phosphate', 'interventionNames': ['Other: Diet containing organic phosphate']}, {'type': 'EXPERIMENTAL', 'label': 'Phosphate modified diet with inorganic phosphate', 'interventionNames': ['Other: Diet containing inorganic phosphate']}], 'interventions': [{'name': 'Diet containing organic phosphate', 'type': 'OTHER', 'description': 'The patients will be receiving a 5 days diet containing organic phosphate', 'armGroupLabels': ['Phosphate modified diet with organic phosphate']}, {'name': 'Diet containing inorganic phosphate', 'type': 'OTHER', 'description': 'The patients will be receiving a 5 days diet containing inorganic phosphate', 'armGroupLabels': ['Phosphate modified diet with inorganic phosphate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'contacts': [{'name': 'Ditte Hansen, MD', 'role': 'CONTACT', 'email': 'ditte.hansen.04@regionh.dk', 'phone': '+4538682056'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Jens Rikardt Andersen, MD', 'role': 'CONTACT', 'email': 'jra@nexs.ku.dk', 'phone': '+4523346652'}, {'name': 'Stine Rikardt Kristensen', 'role': 'CONTACT', 'email': 'stinekristensen@live.dk', 'phone': '+4528967003'}], 'overallOfficials': [{'name': 'Jens Rikardt Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stine Kristensen', 'class': 'UNKNOWN'}, {'name': 'Gita Krüger Mørch', 'class': 'UNKNOWN'}, {'name': 'Rizwan Butt', 'class': 'UNKNOWN'}, {'name': 'Ditte Hansen', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor at the university of Copenhagen', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}