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

Primary Purpose

Chronic Kidney Disease Requiring Chronic Dialysis

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Diet containing organic phosphate
Diet containing inorganic phosphate
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease Requiring Chronic Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phosphate modified diet with organic phosphate

Phosphate modified diet with inorganic phosphate

Arm Description

Outcomes

Primary Outcome Measures

Plasma levels of phosphate

Secondary Outcome Measures

Changes in p-phosphate
changes in p-calcium
Changes in p-sodium
Changes in p-potassium
changes in p-PTH
Changes in p-FGF23
Changes in p-magnesium
Koncentration of phosphate in peritoneal dialysis fluid
Koncentration of phosphate in urine

Full Information

First Posted
October 19, 2020
Last Updated
March 17, 2021
Sponsor
University of Copenhagen
Collaborators
Stine Kristensen, Gita Krüger Mørch, Rizwan Butt, Ditte Hansen
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1. Study Identification

Unique Protocol Identification Number
NCT04600193
Brief Title
a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
Acronym
RCTOIP
Official Title
a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Stine Kristensen, Gita Krüger Mørch, Rizwan Butt, Ditte Hansen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Requiring Chronic Dialysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phosphate modified diet with organic phosphate
Arm Type
Experimental
Arm Title
Phosphate modified diet with inorganic phosphate
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Diet containing organic phosphate
Intervention Description
The patients will be receiving a 5 days diet containing organic phosphate
Intervention Type
Other
Intervention Name(s)
Diet containing inorganic phosphate
Intervention Description
The patients will be receiving a 5 days diet containing inorganic phosphate
Primary Outcome Measure Information:
Title
Plasma levels of phosphate
Time Frame
six days
Secondary Outcome Measure Information:
Title
Changes in p-phosphate
Time Frame
six days
Title
changes in p-calcium
Time Frame
six days
Title
Changes in p-sodium
Time Frame
six days
Title
Changes in p-potassium
Time Frame
six days
Title
changes in p-PTH
Time Frame
six days
Title
Changes in p-FGF23
Time Frame
six days
Title
Changes in p-magnesium
Time Frame
six days
Title
Koncentration of phosphate in peritoneal dialysis fluid
Time Frame
six days
Title
Koncentration of phosphate in urine
Time Frame
six days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Rikardt Andersen, MD
Phone
+4523346652
Email
jra@nexs.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Stine Rikardt Kristensen
Phone
+4528967003
Email
stinekristensen@live.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Rikardt Andersen, MD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ditte Hansen, MD
Phone
+4538682056
Email
ditte.hansen.04@regionh.dk

12. IPD Sharing Statement

Learn more about this trial

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

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