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Bone in CKD Alkali Response (BICARb Pilot Trial)
Sponsor: Albert Einstein College of Medicine
Summary
The goal of this clinical trial is to test whether potassium citrate improves skeletal health in adults and children with chronic kidney disease. The main questions it aims to answer are: * To evaluate effects of potassium citrate treatment on bone quality and strength. * To evaluate mechanism(s) underlying the effects of potassium citrate on skeletal health. Participants will be asked to: * provide blood, urine and answer questions about health and diet three times during an 8 months period * undergo advanced bone imaging with high resolution-peripheral quantitative CT scan twice during 8 months * take study pills for 4-6 weeks at the beginning of the study to ensure safety * take either potassium citrate or placebo for 6 months during the blinded portion of the study As part of the study, there will be a run-in period followed by the placebo-controlled randomized clinical trial. Researchers will compare the bone imaging between the potassium citrate and the placebo groups at the end of the study.
Official title: Bone in CKD Alkali Response Pilot Trial (BICARb)
Key Details
Gender
All
Age Range
5 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
103
Start Date
2024-08-15
Completion Date
2026-08
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
Potassium Citrate Extended Release Oral Tablet
Oral potassium citrate extended-release tablet
Placebo
Placebo capsule identical to active ingredient
Potassium Citrate and Citric Acid Oral Solution
Oral potassium citrate and citric acid
Locations (2)
Albert Einstein College of Medicine
The Bronx, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States