Acid-Base Compensation in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— ABC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427594
• Other study ID #: Pro00058905
• Secondary ID: K23DK095949
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2015
• Last updated: August 29, 2017
• Start date: April 2015
• Est. completion date: August 25, 2017

Study information

• Verified date: April 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 25, 2017
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.

Other:
• Controlled diet
Diet without sodium bicarbonate supplementation

Locations

Country	Name	City	State
United States	Duke University School of Medicine	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences in metabolomic profiles	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.	Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks
Primary	Change in ambulatory blood pressure	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.	Measured at the end of each week of intervention (i.e. one week apart)
Primary	Change in urine net acid excretion	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.	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	Change in clinic blood pressure	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.	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)
Secondary	Change in plasma nitric oxide metabolites	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.	Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks