N/A
N=3
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
Phosphorus and Calcium Disorders · Chronic Kidney Disease Mineral and Bone Disorder · Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04019379 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Fractional Calcium Absorption — 0.30; 0.42 fraction of 1.00
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Phosphorus Diet (Other); Low Phosphorus Diet (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fractional Calcium Absorption |
0.30; 0.42 | — |
| PRIMARY Fractional Phosphorus Absorption |
0.73; 0.69 | — |
| PRIMARY Calcium Balance |
126; 199 | — |
| PRIMARY Phosphorus Balance |
65; 73 | — |
| SECONDARY Serum Intact Fibroblast Growth Factor 23 (iFGF23) |
67.9; 53.4 | — |
| SECONDARY Serum Intact Parathyroid Hormone (iPTH) |
122.7; 104.7 | — |
| SECONDARY Serum 1,25-dihydroxyvitamin D (1,25D) |
29.7; 29.7 | — |
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.
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
- 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 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04019379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.