Acid-Base Compensation in Chronic Kidney Disease

NCT ID: NCT02427594

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-08-25

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Controlled diet first

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).

Group Type: EXPERIMENTAL

Sodium bicarbonate

Intervention Type: DRUG

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

Controlled diet

Intervention Type: OTHER

Diet without sodium bicarbonate supplementation

Sodium bicarbonate first

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).

Group Type: EXPERIMENTAL

Sodium bicarbonate

Intervention Type: DRUG

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

Controlled diet

Intervention Type: OTHER

Diet without sodium bicarbonate supplementation

Interventions

Sodium bicarbonate

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

Intervention Type: DRUG

Controlled diet

Diet without sodium bicarbonate supplementation

Intervention Type: OTHER

Other Intervention Names

Baking powder

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Scialla

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University School of Medicine

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33810868 (View on PubMed)

Other Identifiers

K23DK095949

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00058905

Identifier Type: -

Identifier Source: org_study_id