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

NCT ID: NCT04019379

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2023-01-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Sequence A

High Phos crossover to Low Phos

Group Type: EXPERIMENTAL

High Phosphorus Diet

Intervention Type: OTHER

Controlled research diet of high phosphorus (with low calcium)

Low Phosphorus Diet

Intervention Type: OTHER

Controlled research diet of low phosphorus (with low calcium)

Sequence B

Low Phos crossover to High Phos

Group Type: EXPERIMENTAL

High Phosphorus Diet

Intervention Type: OTHER

Controlled research diet of high phosphorus (with low calcium)

Low Phosphorus Diet

Intervention Type: OTHER

Controlled research diet of low phosphorus (with low calcium)

Interventions

High Phosphorus Diet

Controlled research diet of high phosphorus (with low calcium)

Intervention Type: OTHER

Low Phosphorus Diet

Controlled research diet of low phosphorus (with low calcium)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men or women, ages 30-75 years old, any race or ethnicity
• Moderate chronic kidney disease
• Female subjects must be postmenopausal (>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test

Exclusion Criteria

• Willing to discontinue nutritional supplements (e.g. vitamin D, calcium, multivitamin/minerals, or others) upon enrollment until completion of the study
• Adequate vitamin D status defined as serum 25D > 20 ng/mL

• Plans to initiate dialysis within 6 months
• Hypercalcemia defined as serum calcium >10.5 mg/dL within past 3 months
• Hyperkalemia defined as serum potassium >5.5 mg/dL within past 3 months
• Hyperphosphatemia defined as serum phosphate >5.5 mg/dL within past 3 months
• Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, or bariatric surgery
• Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension
• Pregnant or breastfeeding
• Prescribed a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, parathyroid hormone analogues, and other medications that may alter Ca and P metabolism within past 30 days

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen M Hill Gallant, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Indiana CTSI CRC

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1809583731

Identifier Type: -

Identifier Source: org_study_id