RecruitingPhase 2NCT04984226

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Randomized Cross-over Trial of Sodium Bicarbonate on Muscle Mitochondrial Energetics and Physical Endurance in Chronic Kidney Disease and Metabolic Acidosis

Sponsor

University of California, Davis

Enrollment

80 participants

Start Date

Sep 8, 2023

Study Type

INTERVENTIONAL

Conditions

Insulin Resistance Chronic Kidney Diseases Fatigue Diabetes Metabolic Acidosis Physical Endurance Mitochondrial Energetics

Summary

Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.

Eligibility

Min Age: 21 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking sodium bicarbonate (baking soda) — a supplement that neutralizes acid in the blood — can improve how mitochondria (the energy-producing structures in cells) work in people with chronic kidney disease (CKD) who have too much acid in their blood. **You may be eligible if...** - You are between 21 and 85 years old - You have moderate-to-severe CKD (low kidney filtering ability confirmed at least twice) - You have metabolic acidosis — too much acid in your blood — confirmed by blood tests **You may NOT be eligible if...** - You have type 1 diabetes or poorly controlled type 2 diabetes - You are on kidney dialysis or expected to start dialysis during the study - You have a pacemaker or metal implants that make MRI scans unsafe - You are pregnant, breastfeeding, or planning to become pregnant - You have severe blood pressure, heart, liver, or mobility problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium 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.

DRUGplacebo

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.