80
Participants
Start Date
September 8, 2023
Primary Completion Date
December 31, 2025
Study Completion Date
July 30, 2026
Sodium bicarbonate
Sodium bicarbonate will be dosed at 0.8meq per kilogram of ideal body weight daily (1meq is approximately 84mg). We will use the Devine formula to determine ideal body weight. Investigational Drug Services at both UC Davis and Vanderbilt will compound the sodium bicarbonate. Sodium bicarbonate 650 mg tablets will be over-encapsulated and matching placebo capsules will be prepared. Participants will be limited to a maximum of 9 capsules daily (maximum dose = 5850mg of sodium bicarbonate). Capsules will be dispensed to patients in two separate 8-week allotments. The dose will be rounded to the nearest whole capsule and depending on participant preference may be divided into portions taken twice or thrice daily. Given the high probability of interruption in sodium bicarbonate supply and availability, we may need to change brands of sodium bicarbonate intermittently.
placebo
The placebo and filler for for sodium bicarbonate capsules will be comprised of microcrystalline cellulose. Capsule appearance for control and sodium bicarbonate will be the same.
NOT_YET_RECRUITING
Vanderbilt University Medical Center, Nashville
RECRUITING
University of California Davis Health, Sacramento
Vanderbilt University Medical Center
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of California, Davis
OTHER