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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888290
First Posted: April 27, 2009
Last Update Posted: February 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michal L. Melamed, Albert Einstein College of Medicine of Yeshiva University
  Purpose
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.

Condition Intervention Phase
Chronic Kidney Disease Drug: Sodium bicarbonate Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

Resource links provided by NLM:


Further study details as provided by Michal L. Melamed, Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • serum bicarbonate levels [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • muscle strength as measured by sit-to stand test [ Time Frame: 8 weeks ]
  • Blood pressure [ Time Frame: 8 weeks ]

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
Crossover design. Participants will be getting either placebo or different doses of sodium bicarbonate during the study.
Drug: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888290


Locations
United States, New York
Albert Einstein College of Medicine/ Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Thomas Hostetter, MD Albert Einstein College of Medicine, Inc.
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michal L. Melamed, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00888290     History of Changes
Other Study ID Numbers: CCI#2008-376
First Submitted: April 23, 2009
First Posted: April 27, 2009
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Michal L. Melamed, Albert Einstein College of Medicine of Yeshiva University:
metabolic acidosis
chronic kidney disease
Estimated GFR 15-45

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency