NCT03281928

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

5.1 years

First QC Date

September 8, 2017

Last Update Submit

April 16, 2025

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (1)

  • Urine Calcium levels

    Amount of calcium in the urine will be measured

    10 days

Study Arms (4)

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

Interventions

Sodium and Potassium CitrateDIETARY_SUPPLEMENT

Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.

High Sodium plus Potassium CitrateLow Sodium plus Potassium Citrate
PlaceboDIETARY_SUPPLEMENT

Sodium without Potassium Citrate

High Sodium plus placeboLow Sodium plus placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

SodiumPotassium Citrate

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 13, 2017

Study Start

October 1, 2017

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations

US(1)