Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04019379
• Other study ID #: 1809583731
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: December 1, 2023
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Chronic Kidney Disease Mineral and Bone Disorder
• Chronic Kidney Disease-Mineral and Bone Disorder
• Chronic Kidney Diseases
• Disease
• Kidney Diseases
• Phosphorus and Calcium Disorders
• Renal Insufficiency, Chronic

Intervention

Other:
• Low Calcium/High Phosphorus Diet
Controlled research diet of low calcium/high phosphorus
• High Calcium/Low Phosphorus Diet
Controlled research diet of high calcium/low phosphorus

Locations

Country	Name	City	State
United States	Indiana CTSI CRC	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional calcium absorption	Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations	48 hours
Primary	Fractional phosphorus absorption	Determined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations	48 hours
Primary	Calcium balance	Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed.	2 weeks
Primary	Phosphorus balance	Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed.	2 weeks
Primary	Calcium kinetic model	Determined by kinetic modeling of serum, urine, and fecal Ca-44 isotope after oral and IV isotope administrations	2 weeks
Primary	Phosphorus kinetic model	Determined by kinetic modeling of serum, urine, and fecal P-33 isotope after oral and IV isotope administrations	2 weeks
Secondary	Creatinine clearance rate		24 hours, Day 8
Secondary	Plasma fibroblast growth factor 23 concentration		Day 1, Day 8
Secondary	Plasma parathyroid hormone concentration		Day 1, Day 8
Secondary	Plasma 1,25-dihydroxyvitamin D concentration		Day 1, Day 8
Secondary	Plasma phosphate concentration		Day 1, Day 8
Secondary	Plasma calcium concentration		Day 1, Day 8