Pilot Study of Sodium Bicarbonate in Generally Healthy People With Low Bicarbonate

November 11, 2018 updated by: Kalani Raphael, University of Utah
The goal of this pilot study is to determine whether oral sodium bicarbonate can raise low serum bicarbonate concentration in people without chronic kidney disease (CKD). Participants will take sodium bicarbonate for six weeks, followed by a four week washout period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

CKD affects 25 million Americans and the risks of cardiovascular morbidity, hospitalizations, and death are substantially higher for people with CKD. Furthermore, 6% of the total Medicare budget is spent on 600,000 people with end-stage renal disease. Thus, CKD is highly prevalent, associates with poor outcomes, and is a tremendous financial burden to society.

Apart from treating hypertension and diabetes, there are no therapies that prevent CKD. However, results from two studies have found that low serum bicarbonate levels increase risk of developing CKD, which suggests that normalizing low serum bicarbonate may prevent CKD.

One way to raise low serum bicarbonate is by taking sodium bicarbonate. Whether sodium bicarbonate, which is commonly prescribed to raise low serum bicarbonate in people with CKD, can raise low bicarbonate in people without CKD is uncertain because the reason bicarbonate is low in people without CKD is unclear. This is because low bicarbonate by itself cannot distinguish whether the acid-base abnormality is primary metabolic acidosis or respiratory alkalosis. The former process is readily corrected with alkali. However, the administration of alkali in the latter situation may not raise bicarbonate concentration.

Therefore, the purpose of this pilot study is to determine whether oral sodium bicarbonate can raise low serum bicarbonate in people without renal disease.

The study is a single-arm open label study of 15 individuals without CKD with low serum bicarbonate concentration. The study duration is 10 weeks. After completing the baseline visit, participants will take oral sodium bicarbonate (initial dose level: 0.3 milliequivalents per kilogram per day (mEq/kg/d) for 6 weeks (On-treatment period), followed by a 4 week Off-treatment period. Serum concentrations of sodium bicarbonate will be tested during the treatment period, at the end of the On-treatment period (Week 6) and at the end of the Off-treatment period (Week 10).

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • VA Salt Lake City Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m2
  • Urinary albumin/creatinine ratio < 30 mg/gm
  • Serum bicarbonate ≤ 23 mEq/L (average of the two most recent measurements within the past year)
  • Age ≥ 50 years

Exclusion Criteria:

  • Blood pressure ≥ 160/100 mm Hg
  • Serum potassium < 3.5 mEq/L
  • New York Heart Association Class 3 or 4 heart failure symptoms
  • Chronic oxygen therapy
  • Chronic obstructive pulmonary disease requiring daily bronchodilator or prednisone therapy
  • Weight ≥ 160 kg
  • Use of sodium bicarbonate, sodium citrate, potassium citrate, or potassium bicarbonate within the previous two weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium Bicarbonate

All participants will receive oral sodium bicarbonate for 6 weeks (On-treatment period). After the 6 week visit, participants will stop taking sodium bicarbonate and return for a final visit 4 weeks later (Off-treatment period).

The initial dose of sodium bicarbonate prescribed is 0.3 mEq/kg/d. If a subject meets the protocol criteria, the dose will be increased to 0.6 mEq/kg/d. Half the dose will be taken by mouth in the morning and the other half in the evening.
Dietary supplement: Sodium bicarbonate
The initial dose of sodium bicarbonate is 0.3 mEq/kg/d. If a subject meets the protocol criteria, the dose will be increased to 0.6 mEq/kg/d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum bicarbonate concentration from baseline to 6 weeks
Time Frame: Baseline and 6 weeks
Comparison of pre-intervention serum bicarbonate levels to week 6 levels following treatment with oral sodium bicarbonate.
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum bicarbonate concentration after 4 weeks of stopping sodium bicarbonate treatment
Time Frame: Baseline, 6 weeks and 10 weeks
Comparison of serum bicarbonate levels four weeks after discontinuing oral sodium bicarbonate treatment to pre-intervention (baseline) and immediate post-treatment (week 6) serum bicarbonate levels.
Baseline, 6 weeks and 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

The University of Utah Center on Aging

Investigators

  • Principal Investigator: Kalani L Raphael, MD, VA Salt Lake City Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 14, 2017

Study Completion (Actual)

June 14, 2017

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 11, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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