Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling

October 8, 2021 updated by: University of Chicago
This study intends to characterize the affect of sodium and potassium citrate in the diet on renal function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Sodium plus Potassium Citrate
Dietary supplement: Sodium and Potassium Citrate
Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.
Placebo Comparator: Low Sodium plus placebo
Dietary supplement: Placebo
Sodium without Potassium Citrate
Experimental: High Sodium plus Potassium Citrate
Dietary supplement: Sodium and Potassium Citrate
Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.
Placebo Comparator: High Sodium plus placebo
Dietary supplement: Placebo
Sodium without Potassium Citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine Calcium levels
Time Frame: 10 days
Amount of calcium in the urine will be measured
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Anticipated)

December 20, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB17-0992

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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