Acid-Base Compensation in Chronic Kidney Disease

Completed · Phase 1

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT02427594

Run by

Duke University

People needed

14

Starts

2015-04-01

Expected to finish

2017-08-25

Last updated by the study team

2017-08-30

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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