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Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling

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ClinicalTrials.gov Identifier: NCT03281928
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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

Condition or disease Intervention/treatment Phase
Kidney Stone Dietary Supplement: Sodium and Potassium Citrate Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2020


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




Primary Outcome Measures :
  1. Urine Calcium levels [ Time Frame: 10 days ]
    Amount of calcium in the urine will be measured



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281928


Contacts
Contact: Elaine Worcester 773-702-3630 eworcest@uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Elaine Worcester, MD    773-702-3630    eworcest@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03281928     History of Changes
Other Study ID Numbers: IRB17-0992
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Citric Acid
Potassium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents