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

NCT04019379 | Completed Results DMC

• 1 other identifier: 1809583731
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Phosphorus and Calcium Disorders; Chronic Kidney Disease Mineral and Bone Disorder; Chronic Kidney Diseases

Keywords

Whole-body balance; Kinetic modeling; Intestinal absorption

Outcome Measures

Primary Outcomes (4)

• Fractional Calcium Absorption

  Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations

  48 hours

• Fractional Phosphorus Absorption

  Determined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations

  48 hours

• Calcium Balance

  Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed. Values can be negative, zero, or positive.

  1 week

• Phosphorus Balance

  Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed. Values can be negative, zero, or positive.

  1 weeks

Secondary Outcomes (3)

• Serum Intact Fibroblast Growth Factor 23 (iFGF23)

  Day 1-8

• Serum Intact Parathyroid Hormone (iPTH)

  Day 1-8

• Serum 1,25-dihydroxyvitamin D (1,25D)

  Day 1

Study Arms (2)

Sequence A

EXPERIMENTAL

High Phos crossover to Low Phos

Other: High Phosphorus Diet; Other: Low Phosphorus Diet

Sequence B

EXPERIMENTAL

Low Phos crossover to High Phos

Other: High Phosphorus Diet; Other: Low Phosphorus Diet

Interventions

High Phosphorus Diet OTHER

Controlled research diet of high phosphorus (with low calcium)

Sequence A; Sequence B

Low Phosphorus Diet OTHER

Controlled research diet of low phosphorus (with low calcium)

Sequence A; Sequence B

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Indiana University: collaborator

Study Sites (1)

Indiana CTSI CRC

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency

Results Point of Contact

• Title: Kathleen M. Hill Gallant, PhD
• Organization: University of Minnesota

hillkm@umn.edu

612-625-5285

Study Officials

• Kathleen M Hill Gallant, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 15, 2019
• Study Start: August 31, 2020
• Primary Completion: October 28, 2020
• Study Completion: January 30, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Locations

US (1)