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

University of Copenhagen

Status: Unknown

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Other: Diet containing organic phosphate; Other: Diet containing inorganic phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT04600193

IOOAIOP

Details and patient eligibility

About

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Phosphate modified diet with organic phosphate

Experimental group

Treatment:

Other: Diet containing organic phosphate

Phosphate modified diet with inorganic phosphate

Experimental group

Treatment:

Other: Diet containing inorganic phosphate