NCT04019379

Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.

Detailed description

The goal of this project is to produce preliminary data on the effects of the commonly prescribed dietary phosphorus restriction on whole-body Calcium (Ca) and Phosphorus (P) balance and kinetics patients with CKD, to support a larger future clinical study. The specific aims are to determine intestinal Ca and P fractional absorption and 2) Ca and P balance and full kinetics, effect sizes variance estimates in patients with CKD on a low Ca diet with high P diet versus dietary P restriction. The hypothesis is that a high P diet, in the context of a typical low Ca diet, leads to P retention negative Ca balance, and that dietary P restriction modestly reduces P retention but does not negative Ca balance. The study design is a randomized 2-period cross-over study. All outpatient and inpatient visits place at the Indiana CTSI Clinical Research Center located in IU Health University Hospital in Indianapolis, IN. Subjects will be randomly assigned to controlled diets of either low Ca/high P (LCa/HP) or low (LCa/LP) for a 1-week, outpatient diet equilibration period, followed by 1-week inpatient full balance that includes a 48-hour Ca and P absorption testing protocol. After a 1-3 week washout subjects will crossover to the other diet regimen

Conditions

• Phosphorus and Calcium Disorders
• Chronic Kidney Disease Mineral and Bone Disorder
• Chronic Kidney Diseases

Interventions

Type	Name	Description
OTHER	High Phosphorus Diet	Controlled research diet of high phosphorus (with low calcium)
OTHER	Low Phosphorus Diet	Controlled research diet of low phosphorus (with low calcium)

Timeline

• Start date: 2020-08-31
• Primary completion: 2020-10-28
• Completion: 2023-01-30
• First posted: 2019-07-15
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States