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

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Placebos; Drug: Sodium bicarbonate

• Registration Number: NCT00888290
• Lead Sponsor: Albert Einstein College of Medicine

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2020-06-22
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-12
• Last Update Submitted: 2022-08-12
• Results First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebos	Placebos	Sequential design. Participants will be getting either placebo of different doses during the study.
Sodium Bicarbonate	Sodium bicarbonate	Sequential design. Participants will be getting different doses of sodium bicarbonate during the study.

Primary Outcome Measures

Name	Time	Method
Serum Bicarbonate Levels	8 weeks

Secondary Outcome Measures

Name	Time	Method
Muscle Strength as Measured by sit-to Stand Test	8 weeks	10 repetition sit-to-stand test
Systolic Blood Pressure	8 weeks

Trial Locations

Locations (1)

Albert Einstein College of Medicine/ Montefiore Medical Center; 🇺🇸 Bronx, New York, United States