Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
Overview
- Phase
- Phase 2
- Intervention
- Sodium bicarbonate
- Conditions
- Chronic Kidney Disease
- Sponsor
- Albert Einstein College of Medicine
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Serum Bicarbonate Levels
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.
Detailed Description
This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.
Investigators
Michal L. Melamed
Assistant Professor
Albert Einstein College of Medicine
Eligibility Criteria
Inclusion Criteria
- •Estimated GFR \< 45 ml/min/1.73m2 and \>15 ml/min/1.73 m2 determined by abbreviated 4 variable modification MDRD equation
Exclusion Criteria
- •Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
- •Bicarbonate level \<20 or \>25 mEq/L
- •Decompensated heart failure
- •Systolic blood pressure \>160 mm/Hg
- •Moderate or greater lower extremity edema
- •Initiation of ESRD treatment planned within 6 months
- •Kidney transplantation
- •Treatment with immunosuppressives within the last 3 months
Arms & Interventions
Sodium Bicarbonate
Sequential design. Participants will be getting different doses of sodium bicarbonate during the study.
Intervention: Sodium bicarbonate
Placebos
Sequential design. Participants will be getting either placebo of different doses during the study.
Intervention: Placebos
Outcomes
Primary Outcomes
Serum Bicarbonate Levels
Time Frame: 8 weeks
Secondary Outcomes
- Muscle Strength as Measured by sit-to Stand Test(8 weeks)
- Systolic Blood Pressure(8 weeks)