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

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

— RCTOIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04600193
• Other study ID #: IOOAIOP
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: University of Copenhagen
• Contact: Jens Rikardt Andersen, MD
• Phone: +4523346652
• Email: jra[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Diet containing organic phosphate
The patients will be receiving a 5 days diet containing organic phosphate
• Diet containing inorganic phosphate
The patients will be receiving a 5 days diet containing inorganic phosphate

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (5)

Lead Sponsor	Collaborator
University of Copenhagen	Ditte Hansen, Gita Krüger Mørch, Rizwan Butt, Stine Kristensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of phosphate		six days
Secondary	Changes in p-phosphate		six days
Secondary	changes in p-calcium		six days
Secondary	Changes in p-sodium		six days
Secondary	Changes in p-potassium		six days
Secondary	changes in p-PTH		six days
Secondary	Changes in p-FGF23		six days
Secondary	Changes in p-magnesium		six days
Secondary	Koncentration of phosphate in peritoneal dialysis fluid		six days
Secondary	Koncentration of phosphate in urine		six days