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NCT06712719
Effects of Dietary Phosphorus on Phosphorus and Calcium Whole-Body Balance and Kinetics in Moderate CKD
Conditions: CKD
Sex: All
Ages: 30 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 14
Sponsor: University of Minnesota
Location: Indiana University School of Medicine Indianapolis Indiana
Summary
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
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT06712719). StuddyBuddy aggregates publicly available trial information.