Dietary Phosphorus for Chronic Kidney Disease

KH
SC
Overseen ByStudy Coordinator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The aim of the study is to look at the effects of dietary phosphorus on phosphorous and calcium whole-body balance and kinetics in moderate chronic kidney disease (CKD). N = 14 enrolled subjects will be randomly assigned to a cross-over order of (A) Low P Diet, High P Diet. Each cross-over phase will be 19 days and consist of a 7-day outpatient, controlled diet period, followed by a 5- day inpatient, controlled diet, balance, and kinetic study period, followed by a second 7-day outpatient, controlled diet period.

Who Is on the Research Team?

KH

Kathleen Hill Gallant, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for men and women aged 30-75 with moderate chronic kidney disease (CKD), specifically those whose kidney function falls within a certain range. Women must be postmenopausal or not pregnant, and participants should have stable medication doses.

Inclusion Criteria

I am taking stable doses of my medications.
I have moderate chronic kidney disease with reduced kidney function and protein in my urine.
I am a woman who cannot become pregnant or is confirmed not pregnant.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Cross-over Phase 1

Participants follow a controlled diet with either low or high phosphorus for 19 days, including a 7-day outpatient period, a 5-day inpatient period with phosphorus isotope administration, and a final 7-day outpatient period.

19 days
7-day outpatient, 5-day inpatient, 7-day outpatient

Washout Period

Participants undergo a washout period between cross-over sessions.

1-3 weeks

Cross-over Phase 2

Participants switch diets and repeat the same study process as the first session.

19 days
7-day outpatient, 5-day inpatient, 7-day outpatient

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests how eating diets with low versus high phosphorus affects phosphorus and calcium balance in people with moderate CKD. Each person tries both diets in different order during two separate phases lasting about three weeks each.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: CKD patients group 2Experimental Treatment1 Intervention
Group II: CKD patients group 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Indiana University

Collaborator

Trials
1,063
Recruited
1,182,000+