Back to resultsCalcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
Primary Purpose
Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Calcium/High Phosphorus Diet
High Calcium/Low Phosphorus Diet
Sponsored by
About this trial
This is an interventional basic science trial for Phosphorus and Calcium Disorders focused on measuring Whole-body balance, Kinetic modeling, Intestinal absorption
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
Sites / Locations
- Indiana CTSI CRC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence A
Sequence B
Arm Description
Low Ca/High Phos crossover to Low Ca/Low Phos
Low Ca/Low Phos crossover to Low Ca/High Phos
Outcomes
Primary Outcome Measures
Fractional calcium absorption
Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations
Fractional phosphorus absorption
Determined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations
Calcium balance
Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed.
Phosphorus balance
Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed.
Calcium kinetic model
Determined by kinetic modeling of serum, urine, and fecal Ca-44 isotope after oral and IV isotope administrations
Phosphorus kinetic model
Determined by kinetic modeling of serum, urine, and fecal P-33 isotope after oral and IV isotope administrations
Secondary Outcome Measures
Creatinine clearance rate
Plasma fibroblast growth factor 23 concentration
Plasma parathyroid hormone concentration
Plasma 1,25-dihydroxyvitamin D concentration
Plasma phosphate concentration
Plasma calcium concentration
Full Information
NCT ID
NCT04019379
First Posted
July 9, 2019
Last Updated
January 4, 2023
Sponsor
University of Minnesota
Collaborators
Indiana University
1. Study Identification
Unique Protocol Identification Number
NCT04019379
Brief Title
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
Official Title
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases
Keywords
Whole-body balance, Kinetic modeling, Intestinal absorption
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Low Ca/High Phos crossover to Low Ca/Low Phos
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Low Ca/Low Phos crossover to Low Ca/High Phos
Intervention Type
Other
Intervention Name(s)
Low Calcium/High Phosphorus Diet
Intervention Description
Controlled research diet of low calcium/high phosphorus
Intervention Type
Other
Intervention Name(s)
High Calcium/Low Phosphorus Diet
Intervention Description
Controlled research diet of high calcium/low phosphorus
Primary Outcome Measure Information:
Title
Fractional calcium absorption
Description
Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations
Time Frame
48 hours
Title
Fractional phosphorus absorption
Description
Determined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations
Time Frame
48 hours
Title
Calcium balance
Description
Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed.
Time Frame
2 weeks
Title
Phosphorus balance
Description
Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed.
Time Frame
2 weeks
Title
Calcium kinetic model
Description
Determined by kinetic modeling of serum, urine, and fecal Ca-44 isotope after oral and IV isotope administrations
Time Frame
2 weeks
Title
Phosphorus kinetic model
Description
Determined by kinetic modeling of serum, urine, and fecal P-33 isotope after oral and IV isotope administrations
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Creatinine clearance rate
Time Frame
24 hours, Day 8
Title
Plasma fibroblast growth factor 23 concentration
Time Frame
Day 1, Day 8
Title
Plasma parathyroid hormone concentration
Time Frame
Day 1, Day 8
Title
Plasma 1,25-dihydroxyvitamin D concentration
Time Frame
Day 1, Day 8
Title
Plasma phosphate concentration
Time Frame
Day 1, Day 8
Title
Plasma calcium concentration
Time Frame
Day 1, Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Hill Gallant, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana CTSI CRC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
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