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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Other: Diet containing organic phosphate
* Other: Diet containing inorganic phosphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phosphate modified diet with organic phosphate<br> | Other: Diet containing organic phosphate<br>* The patients will be receiving a 5 days diet containing organic phosphate<br>|
| Experimental: Phosphate modified diet with inorganic phosphate<br> | Other: Diet containing inorganic phosphate<br>* The patients will be receiving a 5 days diet containing inorganic phosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of phosphate |  | six days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Changes in p-FGF23 |  | six days | 
| Changes in p-magnesium |  | six days | 
| Koncentration of phosphate in peritoneal dialysis fluid |  | six days | 
| Koncentration of phosphate in urine |  | six days |