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Effect of a High Citrate Beverage on Urine Chemistry in Urinary Stone Disease

NCT04697706 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-01-06

No results posted yet for this study

Summary

This study will investigate the effect of a patented high citrate beverage on urine chemistry in patients with urinary stone disease (USD). It is a minimal risk study of an over-the-counter beverage called Moonstone, which is commercially available. This study is considered preparatory for the RO-1 and is not intended to produce a definitive outcome regarding kidney stones.

Conditions

  • Urinary Stone

Interventions

DIETARY_SUPPLEMENT

Moonstone

Participants will take one packet of Moonstone powder reconstituted in 500 ml water, twice a day, to total 1 L per day (66 meq of potential alkali/day) plus ad lib fluids. Moonstone packets will be supplied by Dr. Arnie's, Inc. Participants will follow their own self-chosen ad lib diets and complete a diet diary (Appendix) for days 6 and 7 in the first study period. On day 7, a 24-hour urine collection will be performed, and a 50-ml aliquot of urine will be sent to Litholink (Chicago, IL) via FedEx for analysis. Participants will then continue to the second study period and will use the diet diary completed in the first study period on days 6 and 7 to reproduce the identical diets for days 6 and 7 of the subsequent collection period.

OTHER

Water

Participants will take in 1L of tap water per day plus ad lib, self-selected fluids. Participants will follow their own self-chosen ad lib diets and complete a diet diary (Appendix) for days 6 and 7 in the first study period. On day 7, a 24-hour urine collection will be performed, and a 50-ml aliquot of urine will be sent to Litholink (Chicago, IL) via FedEx for analysis. Participants will then continue to the second study period and will use the diet diary completed in the first study period on days 6 and 7 to reproduce the identical diets for days 6 and 7 of the subsequent collection period.

Sponsors & Collaborators

Principal Investigators

  • David Goldfarb, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2020-12-14
Completion
2020-12-14

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697706 on ClinicalTrials.gov