Phase 3
Completed N=20
Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
Chronic Kidney Disease
Source: ClinicalTrials.gov NCT00888290 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Serum Bicarbonate Levels — 25.5; 22.2 mEq/L
◆ Published Evidence
Highly cited
132citations · ~10 / year
Effects of oral sodium bicarbonate in patients with CKD.
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.
Linked Publications (2)
-
Effects of oral sodium bicarbonate in patients with CKD.
-
Effect of oral sodium bicarbonate on fibroblast growth factor-23 in patients with chronic kidney disease: a pilot study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Bicarbonate Levels |
25.5; 22.2 | — |
| SECONDARY Muscle Strength as Measured by sit-to Stand Test |
22.2; 23.8 | — |
| SECONDARY Systolic Blood Pressure |
127; 129 | — |
Eligibility Criteria
Inclusion Criteria
- Estimated GFR 15 ml/min/1.73 m2 determined by abbreviated 4 variable modification MDRD equation
- Age >21
Exclusion Criteria
- Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
- Bicarbonate level 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
Data sourced from ClinicalTrials.gov (NCT00888290) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.