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a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients

a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04600193
Acronym
RCTOIP
Enrollment
21
Registered
2020-10-23
Start date
2021-03-17
Completion date
2021-12-31
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

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.

Interventions

OTHERDiet containing organic phosphate

The patients will be receiving a 5 days diet containing organic phosphate

OTHERDiet containing inorganic phosphate

The patients will be receiving a 5 days diet containing inorganic phosphate

Sponsors

Stine Kristensen
CollaboratorUNKNOWN
Gita Krüger Mørch
CollaboratorUNKNOWN
Rizwan Butt
CollaboratorUNKNOWN
Ditte Hansen
CollaboratorUNKNOWN
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Pregnant or breast-feeding * Terminal patients * If the experience acute infections or other acute situations they will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Plasma levels of phosphatesix days

Secondary

MeasureTime frame
changes in p-calciumsix days
Changes in p-sodiumsix days
Changes in p-potassiumsix days
changes in p-PTHsix days
Changes in p-phosphatesix days
Changes in p-magnesiumsix days
Koncentration of phosphate in peritoneal dialysis fluidsix days
Koncentration of phosphate in urinesix days
Changes in p-FGF23six days

Countries

Denmark

Contacts

Primary ContactJens Rikardt Andersen, MD
jra@nexs.ku.dk+4523346652
Backup ContactStine Rikardt Kristensen
stinekristensen@live.dk+4528967003

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026