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Acid-Base Compensation in Chronic Kidney Disease (ABC)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sodium bicarbonate
Controlled diet
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Kidney Diseases, Renal Insufficiency, Chronic, Dietary nonvolatile acid load, Blood pressure, Urine net acid excretion

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Controlled diet first

Sodium bicarbonate first

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change in ambulatory blood pressure
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.
Change in urine net acid excretion
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.

Secondary Outcome Measures

Change in clinic blood pressure
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.
Change in plasma nitric oxide metabolites
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.

Full Information

First Posted
April 23, 2015
Last Updated
August 29, 2017
Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02427594
Brief Title
Acid-Base Compensation in Chronic Kidney Disease
Acronym
ABC
Official Title
Acid-Base Compensation in Chronic Kidney Disease: Measurement and Physiologic Impact
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 25, 2017 (Actual)
Study Completion Date
August 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Kidney Diseases, Renal Insufficiency, Chronic, Dietary nonvolatile acid load, Blood pressure, Urine net acid excretion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controlled diet first
Arm Type
Experimental
Arm Description
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).
Arm Title
Sodium bicarbonate first
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Other Intervention Name(s)
Baking powder
Intervention Description
Drug/dietary supplement is used in a crossover design to lower the nonvolatile acid load of the diet compared to the control period.
Intervention Type
Other
Intervention Name(s)
Controlled diet
Intervention Description
Diet without sodium bicarbonate supplementation
Primary Outcome Measure Information:
Title
Change in ambulatory blood pressure
Description
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.
Time Frame
Measured at the end of each week of intervention (i.e. one week apart)
Title
Change in urine net acid excretion
Description
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.
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)
Secondary Outcome Measure Information:
Title
Change in clinic blood pressure
Description
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.
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)
Title
Change in plasma nitric oxide metabolites
Description
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.
Time Frame
Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks
Other Pre-specified Outcome Measures:
Title
Differences in metabolomic profiles
Description
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.
Time Frame
Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Scialla
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33810868
Citation
Tyson CC, Luciano A, Modliszewski JL, Corcoran DL, Bain JR, Muehlbauer M, Ilkayeva O, Pourafshar S, Allen J, Bowman C, Gung J, Asplin JR, Pendergast J, Svetkey LP, Lin PH, Scialla JJ. Effect of Bicarbonate on Net Acid Excretion, Blood Pressure, and Metabolism in Patients With and Without CKD: The Acid Base Compensation in CKD Study. Am J Kidney Dis. 2021 Jul;78(1):38-47. doi: 10.1053/j.ajkd.2020.10.015. Epub 2021 Mar 31.
Results Reference
derived

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Acid-Base Compensation in Chronic Kidney Disease

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