CompletedPhase 1

Acid-Base Compensation in Chronic Kidney Disease

United States14 participantsStarted 2015-04

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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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

What they're measuring

Change in ambulatory blood pressure

Timeframe: Measured at the end of each week of intervention (i.e. one week apart)

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)

Trial details

NCT IDNCT02427594

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-25

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