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

Not Applicable

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Other: Diet containing inorganic phosphate; Other: Diet containing organic phosphate

• Registration Number: NCT04600193
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Status Verified: 2021-03
• Study Start: 2021-03-17
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phosphate modified diet with inorganic phosphate	Diet containing inorganic phosphate	-
Phosphate modified diet with organic phosphate	Diet containing organic phosphate	-

Primary Outcome Measures

Name	Time	Method
Plasma levels of phosphate	six days

Secondary Outcome Measures

Name	Time	Method
Changes in p-potassium	six days
Koncentration of phosphate in urine	six days
Changes in p-sodium	six days
Changes in p-magnesium	six days
changes in p-calcium	six days
Koncentration of phosphate in peritoneal dialysis fluid	six days
Changes in p-phosphate	six days
changes in p-PTH	six days
Changes in p-FGF23	six days

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark