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

• Sponsor: Albert Einstein College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00888290
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• 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
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. serum bicarbonate levels [8 weeks]

Secondary Outcome Measures

1. muscle strength as measured by sit-to stand test [8 weeks]

2. Blood pressure [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Albert Einstein College of Medicine/ Montefiore Medical Center	Bronx	New York	United States	10461

Sponsors and Collaborators

• Albert Einstein College of Medicine

Investigators

• Principal Investigator: Thomas Hostetter, MD, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michal L. Melamed, Assistant Professor, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT00888290
• Other Study ID Numbers: CCI#2008-376
• First Posted: Apr 27, 2009
• Last Update Posted: Feb 16, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Michal L. Melamed, Assistant Professor, Albert Einstein College of Medicine: metabolic acidosis; chronic kidney disease; Estimated GFR 15-45
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Feb 16, 2015