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

Albert Einstein College of Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Sodium bicarbonate; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT00888290

2008-376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Sodium Bicarbonate

Active Comparator group

Description:

Sequential design. Participants will be getting different doses of sodium bicarbonate during the study.

Treatment:

Drug: Sodium bicarbonate

Placebos

Placebo Comparator group

Description:

Sequential design. Participants will be getting either placebo of different doses during the study.

Treatment:

Drug: Placebos