Status:
COMPLETED
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Indiana University
Conditions:
Phosphorus and Calcium Disorders
Chronic Kidney Disease Mineral and Bone Disorder
Eligibility:
All Genders
30-75 years
Phase:
NA
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04019379
Start Date
August 31 2020
End Date
January 30 2023
Last Update
September 19 2024
Active Locations (1)
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1
Indiana CTSI CRC
Indianapolis, Indiana, United States, 46202