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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sodium Bicarbonate

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

Group Type ACTIVE_COMPARATOR

Sodium bicarbonate

Intervention Type DRUG

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

Placebos

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo at 3 different doses to match Sodium bicarbonate dosing

Interventions

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Sodium bicarbonate

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

Intervention Type DRUG

Placebos

Placebo at 3 different doses to match Sodium bicarbonate dosing

Intervention Type DRUG

Other Intervention Names

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sodium hydrogen carbonate identical-appearing placebo

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No