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

Sponsor

University of Copenhagen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04600193

Collaborator

Stine Kristensen (Other), Gita Krüger Mørch (Other), Rizwan Butt (Other), Ditte Hansen (Other)

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Requiring Chronic Dialysis	Other: Diet containing organic phosphate Other: Diet containing inorganic phosphate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 17, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Plasma levels of phosphate [six days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herlev Hospital	Herlev		Denmark	2730

Sponsors and Collaborators

University of Copenhagen
Stine Kristensen
Gita Krüger Mørch
Rizwan Butt
Ditte Hansen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jens Rikardt Andersen, Associate professor at the university of Copenhagen, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT04600193

Other Study ID Numbers:

IOOAIOP

First Posted:

Oct 23, 2020

Last Update Posted:

Mar 18, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Mar 18, 2021