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

Starting soon · Not applicable

Conditions studied: CKD

In brief

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.

Key facts

Study ID

NCT06712719

Run by

University of Minnesota

People needed

14

Starts

2026-09-01

Expected to finish

2027-05-01

Last updated by the study team

2026-07-10

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study
• 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.

You may not qualify if…

• Plans to initiate dialysis within 6 months
• Hypercalcemia defined as corrected serum calcium >9.8 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, bariatric surgery, or chronic diarrhea/malabsorption
• Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension in the opinion of their physician
• Pregnant or breastfeeding
• Prescribed and taken a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, PTH analogues, and other medications that may alter Ca and P metabolism within past 4 weeks
• Non-English speaking

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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