Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

Albert Einstein College of Medicine20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Kidney Disease

Interventions

Sodium bicarbonateDRUG

Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight

PlacebosDRUG

Placebo at 3 different doses to match Sodium bicarbonate dosing

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Estimated GFR \< 45 ml/min/1.73m2 and \>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 \<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

Locations (1)

Albert Einstein College of Medicine/ Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Serum Bicarbonate Levels

Time frame: 8 weeks

Secondary Outcomes

Muscle Strength as Measured by sit-to Stand Test

10 repetition sit-to-stand test

Time frame: 8 weeks

Systolic Blood Pressure

Time frame: 8 weeks

Data from ClinicalTrials.gov

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