Clinical trial NCT02427594: Acid-Base Compensation in Chronic Kidney Disease
Official title: Acid-Base Compensation in Chronic Kidney Disease: Measurement and Physiologic Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Keywords: Kidney Diseases
Renal Insufficiency, Chronic
Dietary nonvolatile acid load
Blood pressure
Urine net acid excretion
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-04-28
Enrollment: 14
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in ambulatory blood pressure
timeFrame: Measured at the end of each week of intervention (i.e. one week apart)
measure: Change in urine net acid excretion
timeFrame: 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 outcomes:
measure: Change in clinic blood pressure
timeFrame: 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)
measure: Change in plasma nitric oxide metabolites
timeFrame: Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks
Other outcomes:
measure: Differences in metabolomic profiles
timeFrame: Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Julia Scialla
role: PRINCIPAL_INVESTIGATOR
References:
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.