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NCT Number: NCT02427594

Acid-Base Compensation in Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

Drug

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

Other names: Baking powder

Controlled diet

Other

Diet without sodium bicarbonate supplementation

Primary outcomes

  1. Change in ambulatory blood pressure

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

    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.

  2. Change in urine net acid excretion

    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)

    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 outcomes

  1. Change in clinic blood pressure

    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)

    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.

  2. Change in plasma nitric oxide metabolites

    Time frame: Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks

    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.

Other outcomes

  1. Differences in metabolomic profiles

    Time frame: Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: ABC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2015
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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