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Completed

NCT Number: NCT00888290

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

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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Key information

Conditions

Chronic Kidney Disease Acid-Base Imbalance Acidosis Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Albert Einstein College of Medicine/ Montefiore Medical Center

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

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

Other names: sodium hydrogen carbonate

Placebos

Drug

Placebo at 3 different doses to match Sodium bicarbonate dosing

Other names: identical-appearing placebo

Primary outcomes

  1. Serum Bicarbonate Levels

    Time frame: 8 weeks

Secondary outcomes

  1. Muscle Strength as Measured by sit-to Stand Test

    Time frame: 8 weeks

    10 repetition sit-to-stand test

  2. Systolic Blood Pressure

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2009
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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