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

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.
 
ClinicalTrials.gov Identifier: NCT00888290
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Michal L. Melamed, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 27, 2009
Last Update Posted Date February 16, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
serum bicarbonate levels [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
  • muscle strength as measured by sit-to stand test [ Time Frame: 8 weeks ]
  • Blood pressure [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
Official Title  ICMJE Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Single arm
Crossover design. Participants will be getting either placebo or different doses of sodium bicarbonate during the study.
Intervention: Drug: Sodium bicarbonate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2009)
25
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00888290
Other Study ID Numbers  ICMJE CCI#2008-376
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michal L. Melamed, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Hostetter, MD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP