Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling

NCT03281928 — Not applicable, Terminated, 30 participants, University of Chicago

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Registry	NCT03281928
Status	Terminated - Study closed due to IRB expiration. A new protocol (IRB22-1817) was submitted to continue the research.
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: double, other
Enrollment	30 (Actual)
Sponsor	University of Chicago (Other)
Conditions	Kidney Stone
Interventions	Sodium and Potassium Citrate, Placebo (Dietary supplement)
Dates	start 2017-10-01, primary completion 2022-11-15, completion 2022-11-15, first posted 2017-09-13, last updated 2025-04-22
Locations	1 site in United States

-Summary

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

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+Arms and interventions

Arm	Type	Interventions
Low Sodium plus Potassium Citrate	Experimental	Dietary Supplement: Sodium and Potassium Citrate
Low Sodium plus placebo	Placebo comparator	Dietary Supplement: Placebo
High Sodium plus Potassium Citrate	Experimental	Dietary Supplement: Sodium and Potassium Citrate
High Sodium plus placebo	Placebo comparator	Dietary Supplement: Placebo

Sodium and Potassium Citrate (Dietary supplement): Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.
Placebo (Dietary supplement): Sodium without Potassium Citrate

+Outcome measures

Primary outcomes

Urine Calcium levels [10 days]: Amount of calcium in the urine will be measured

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts 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

+Locations (1)

Facility	City	Country	Status
University of Chicago Medical Center	Chicago, Illinois	United States

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