Effects of Dietary Phosphorus on Phosphorus and Calcium Whole-Body Balance and Kinetics in Moderate CKD

ConditionCKD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorUniversity of Minnesota

About 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.

Eligibility criteria

Qualifiers

Men or women, ages 30-75 years old, any race or ethnicity

Moderate CKD, defined by KDIGO as eGFR category 3b (30-44 mL/min) or 4 (16-29 mL/min) with albuminuria categories A1-A3

Serum intact parathyroid hormone above assay normal limit

Female subjects must be postmenopausal (>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test

Disqualifiers

Willing to discontinue 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 based on National Academy of Medicine (then Institute of Medicine) criteria.

Plans to initiate dialysis within 6 months

Hypercalcemia defined as corrected serum calcium >9.8 mg/dL within past 3 months

Trial design

Treatments tested in this trial

  • LP then HP
  • HP then LP

Treatment groups

14 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Minnesota

Lead sponsor

Indiana University

Collaborator