Acid-Base Compensation in Chronic Kidney Disease (ABC)

August 29, 2017 updated by: Duke University

Acid-Base Compensation in Chronic Kidney Disease: Measurement and Physiologic Impact

The purpose of this study is to evaluate changes in urine net acid excretion, blood pressure and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary supplement similar to baking soda. This may be important for patients with kidney disease because they may have difficulty removing all of the dietary acid load from the body in the urine. Participants with and without kidney disease will be recruited. Each participant will be fed a controlled diet for one week with sodium bicarbonate and for one week without sodium bicarbonate to evaluate these changes. The investigators will also determine if the effect of dietary acid load reduction is different in patients with kidney disease compared to those without kidney disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

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
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University School of Medicine

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

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • estimated glomerular filtration rate ≥30 ml/min/1.73m2
  • serum bicarbonate 20-28 mEq/L

Exclusion Criteria:

  • diabetes mellitus
  • uncontrolled hypertension or recent (<3 weeks) titration of blood pressure medications
  • clinically significant volume overload on screening physical examination
  • selected medical conditions other than kidney disease and hypertension (active cancer, chronic liver failure, moderate to severe COPD, New York Heart Association class 2 or greater congestive heart failure, obstructive sleep apnea requiring nightly continuous positive airway pressure, solid organ transplant)
  • use of alkali supplementation
  • body mass index <18.5 or >40 kg/m2
  • ideal body weight <45.5 kg
  • anemia at screening (hematocrit <29% in participants with kidney disease or <33% in healthy participants)
  • pregnancy or breastfeeding
  • allergies, intolerance or unwillingness to consume foods or supplement provided in feeding menu
  • serum calcium less than 8.6 mg/dl on screening laboratories

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Controlled diet first
In this arm participants will first consume a controlled diet plus added table salt (sodium chloride) for one week. They will then consume an identical controlled diet plus sodium bicarbonate for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is <70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).
Drug: Sodium bicarbonate
Drug/dietary supplement is used in a crossover design to lower the nonvolatile acid load of the diet compared to the control period.
Other Names:
  • Baking powder
Other: Controlled diet
Diet without sodium bicarbonate supplementation
Experimental: Sodium bicarbonate first
In this arm participants will first consume a controlled diet plus sodium bicarbonate for one week. They will then consume an identical controlled diet plus added table salt (sodium chloride) for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is <70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).
Drug: Sodium bicarbonate
Drug/dietary supplement is used in a crossover design to lower the nonvolatile acid load of the diet compared to the control period.
Other Names:
  • Baking powder
Other: Controlled diet
Diet without sodium bicarbonate supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ambulatory blood pressure
Time Frame: Measured at the end of each week of intervention (i.e. one week apart)
Change in mean 24 hour systolic and diastolic blood pressure comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.
Measured at the end of each week of intervention (i.e. one week apart)
Change in urine net acid excretion
Time Frame: Urine net acid excretion will be measured at three timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in)
Change in urine net acid excretion comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.
Urine net acid excretion will be measured at three timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinic blood pressure
Time Frame: Clinic blood pressure will be measured at multiple timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in)
Change in average of three readings of systolic and diastolic blood pressure will be evaluated comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.
Clinic blood pressure will be measured at multiple timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in)
Change in plasma nitric oxide metabolites
Time Frame: Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks
Change in nitric oxide metabolites comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.
Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in metabolomic profiles
Time Frame: Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks
Differences in metabolites will be evaluated comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.
Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Julia Scialla, Duke University

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

April 1, 2015

Primary Completion (Actual)

August 25, 2017

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00058905
  • K23DK095949 (U.S. NIH Grant/Contract)

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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