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

March 17, 2021 updated by: Jens Rikardt Andersen, University of Copenhagen
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jens Rikardt Andersen, MD
  • Phone Number: +4523346652
  • Email: jra@nexs.ku.dk

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of phosphate
Time Frame: six days
six days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in p-phosphate
Time Frame: six days
six days
changes in p-calcium
Time Frame: six days
six days
Changes in p-sodium
Time Frame: six days
six days
Changes in p-potassium
Time Frame: six days
six days
changes in p-PTH
Time Frame: six days
six days
Changes in p-FGF23
Time Frame: six days
six days
Changes in p-magnesium
Time Frame: six days
six days
Koncentration of phosphate in peritoneal dialysis fluid
Time Frame: six days
six days
Koncentration of phosphate in urine
Time Frame: six days
six days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Stine Kristensen
Gita Krüger Mørch
Rizwan Butt
Ditte Hansen

Investigators

  • Principal Investigator: Jens Rikardt Andersen, MD, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 17, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOOAIOP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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