Trials / Completed
CompletedNCT04697706
Effect of a High Citrate Beverage on Urine Chemistry in Urinary Stone Disease
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2020-12-14
- Completion
- 2020-12-14
- First posted
- 2021-01-06
- Last updated
- 2021-01-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04697706. Inclusion in this directory is not an endorsement.