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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888290
• Other study ID #: 2008-376
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
• Placebos
Placebo at 3 different doses to match Sodium bicarbonate dosing

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine/ Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

Abramowitz MK, Melamed ML, Bauer C, Raff AC, Hostetter TH. Effects of oral sodium bicarbonate in patients with CKD. Clin J Am Soc Nephrol. 2013 May;8(5):714-20. doi: 10.2215/CJN.08340812. Epub 2013 Feb 7. — View Citation

Chen W, Melamed ML, Hostetter TH, Bauer C, Raff AC, Almudevar AL, Lalonde A, Messing S, Abramowitz MK. Effect of oral sodium bicarbonate on fibroblast growth factor-23 in patients with chronic kidney disease: a pilot study. BMC Nephrol. 2016 Aug 5;17(1):114. doi: 10.1186/s12882-016-0331-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Bicarbonate Levels		8 weeks
Secondary	Muscle Strength as Measured by sit-to Stand Test	10 repetition sit-to-stand test	8 weeks
Secondary	Systolic Blood Pressure		8 weeks