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

Acid-Base Compensation in Chronic Kidney Disease

Sponsors

Lead sponsor: Duke University

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

Source Duke University
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.

Overall Status Completed
Start Date April 2015
Completion Date August 25, 2017
Primary Completion Date August 25, 2017
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in ambulatory blood pressure Measured at the end of each week of intervention (i.e. one week apart)
Change in urine net acid excretion 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 Time Frame
Change in clinic blood pressure 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 Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks
Enrollment 14
Condition
Intervention

Intervention type: Drug

Intervention name: Sodium bicarbonate

Description: Drug/dietary supplement is used in a crossover design to lower the nonvolatile acid load of the diet compared to the control period.

Other name: Baking powder

Intervention type: Other

Intervention name: Controlled diet

Description: Diet without sodium bicarbonate supplementation

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

Gender: All

Minimum age: 22 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Julia Scialla Principal Investigator Duke University
Location
facility Duke University School of Medicine
Location Countries

United States

Verification Date

April 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Controlled diet first

Arm group type: Experimental

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 group label: Sodium bicarbonate first

Arm group type: Experimental

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).

Acronym ABC
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov