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

NCT ID: NCT04600193

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2021-12-31

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.

Detailed Description

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Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Phosphate modified diet with organic phosphate

Group Type EXPERIMENTAL

Diet containing organic phosphate

Intervention Type OTHER

The patients will be receiving a 5 days diet containing organic phosphate

Phosphate modified diet with inorganic phosphate

Group Type EXPERIMENTAL

Diet containing inorganic phosphate

Intervention Type OTHER

The patients will be receiving a 5 days diet containing inorganic phosphate

Interventions

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Diet containing organic phosphate

The patients will be receiving a 5 days diet containing organic phosphate

Intervention Type OTHER

Diet containing inorganic phosphate

The patients will be receiving a 5 days diet containing inorganic phosphate

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stine Kristensen

UNKNOWN

Sponsor Role collaborator

Gita Krüger Mørch

UNKNOWN

Sponsor Role collaborator

Rizwan Butt

UNKNOWN

Sponsor Role collaborator

Ditte Hansen

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jens Rikardt Andersen

Associate professor at the university of Copenhagen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Rikardt Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Jens Rikardt Andersen, MD

Role: CONTACT

+4523346652

Stine Rikardt Kristensen

Role: CONTACT

+4528967003

Facility Contacts

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Ditte Hansen, MD

Role: primary

+4538682056

Other Identifiers

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IOOAIOP

Identifier Type: -

Identifier Source: org_study_id

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