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Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling

Primary Purpose

Kidney Stone

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium and Potassium Citrate
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Stone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 18 - 70, approximately equal numbers of men and women
  • studied by endoscopy with complete papillary mapping and grading
  • stone formers

Exclusion Criteria:

  • Patients with primary renal diseases or renal impairment (eGFR < 90), or medical conditions such as diabetes, or systemic diseases or medications that alter calcium metabolism
  • Patients with known bladder voiding problems

Sites / Locations

  • University of Chicago Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Low Sodium plus Potassium Citrate

Low Sodium plus placebo

High Sodium plus Potassium Citrate

High Sodium plus placebo

Arm Description

Outcomes

Primary Outcome Measures

Urine Calcium levels
Amount of calcium in the urine will be measured

Secondary Outcome Measures

Full Information

First Posted
September 8, 2017
Last Updated
October 8, 2021
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03281928
Brief Title
Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling
Official Title
Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study intends to characterize the affect of sodium and potassium citrate in the diet on renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Sodium plus Potassium Citrate
Arm Type
Experimental
Arm Title
Low Sodium plus placebo
Arm Type
Placebo Comparator
Arm Title
High Sodium plus Potassium Citrate
Arm Type
Experimental
Arm Title
High Sodium plus placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium and Potassium Citrate
Intervention Description
Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Sodium without Potassium Citrate
Primary Outcome Measure Information:
Title
Urine Calcium levels
Description
Amount of calcium in the urine will be measured
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18 - 70, approximately equal numbers of men and women studied by endoscopy with complete papillary mapping and grading stone formers Exclusion Criteria: Patients with primary renal diseases or renal impairment (eGFR < 90), or medical conditions such as diabetes, or systemic diseases or medications that alter calcium metabolism Patients with known bladder voiding problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Worcester
Phone
773-702-3630
Email
eworcest@uchicago.edu
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Worcester
Phone
773-702-7859
Email
eworcest@medicine.bsd.uchicago.edu

12. IPD Sharing Statement

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Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling

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