Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease

• Conditions: Chronic Kidney Disease Mineral and Bone Disorder
• Interventions: Other: Phosphorus Absorption Test

• Registration Number: NCT03108222
• Lead Sponsor: Purdue University

Brief Summary

Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P homeostasis due to progressive loss of kidney function are primary driving forces behind cardiovascular dysfunction and mortality in CKD patients. Intestinal P absorption is an critical aspect in P homeostasis but has been understudied, particularly in the early stages of CKD progression. This study aims to determine P absorption in patients with moderate CKD compared to healthy adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Study Start: 2018-04-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10
• Primary Completion: 2019-08-30
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moderate CKD Subjects	Phosphorus Absorption Test	Subjects with moderate-stage CKD
Healthy Subjects	Phosphorus Absorption Test	Healthy subjects, free of CKD

Primary Outcome Measures

Name	Time	Method
Fractional Phosphorus Absorption	Measured from serial blood draws over a 4-hour time frame	Radiophosphorus (P-33) activity determined by liquid scintillation counting in serum and urine after oral and IV administration will be used to determine fractional phosphate absorption.

Secondary Outcome Measures

Name	Time	Method
Serum 1,25(OH)2D	Measured from baseline measures and serial blood draws over a 4-hour time frame	serum 1,25-dihydroxyvitamin D
Serum FGF23	Measured from baseline measures and serial blood draws over a 4-hour time frame	serum intact and c-terminal FGF23
24h Urine phosphate	measured from two, 24-hour urine collections	24h urine phosphate
Serum phosphate	Measured from baseline measures and serial blood draws over a 4-hour time frame	serum phosphate
Serum parathyroid hormone (PTH)	Measured from baseline measures and serial blood draws over a 4-hour time frame	serum intact parathyroid hormone

Trial Locations

Locations (1)

Purdue University Nutrition Science Department; 🇺🇸 West Lafayette, Indiana, United States