a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
RCTOIP
1 other identifier
interventional
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 18, 2021
March 1, 2021
10 months
October 19, 2020
March 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma levels of phosphate
six days
Secondary Outcomes (9)
Changes in p-phosphate
six days
changes in p-calcium
six days
Changes in p-sodium
six days
Changes in p-potassium
six days
changes in p-PTH
six days
- +4 more secondary outcomes
Study Arms (2)
Phosphate modified diet with organic phosphate
EXPERIMENTALPhosphate modified diet with inorganic phosphate
EXPERIMENTALInterventions
The patients will be receiving a 5 days diet containing organic phosphate
The patients will be receiving a 5 days diet containing inorganic phosphate
Eligibility Criteria
You may qualify if:
- Patients \> 18 years
- Competent
- The patient should be able to take a sample of p-fluid and urine by himself
- Chronic peritoneal dialysis
- Reads and understand danish
- Has been informed written and oraly about the study and signed informed consent
- P-phosphate koncentrations 0,7-2,0 .mol/l
- P - ioniset calcium 1,1-1,4 mmol/l
You may not qualify if:
- Pregnant or breast-feeding
- Terminal patients
- If the experience acute infections or other acute situations they will be excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Stine Kristensencollaborator
- Gita Krüger Mørchcollaborator
- Rizwan Buttcollaborator
- Ditte Hansencollaborator
Study Sites (1)
Herlev Hospital
Herlev, 2730, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Rikardt Andersen, MD
University of Copenhagen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor at the university of Copenhagen
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
March 17, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
March 18, 2021
Record last verified: 2021-03