NCT02427594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
Last Updated

August 30, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

April 23, 2015

Last Update Submit

August 29, 2017

Conditions

Chronic Kidney Disease

Keywords

Kidney DiseasesRenal Insufficiency, ChronicDietary nonvolatile acid loadBlood pressureUrine net acid excretion

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (2)

  • Change in clinic blood pressure

    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 plasma nitric oxide metabolites

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

Other Outcomes (1)

  • Differences in metabolomic profiles

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

Study Arms (2)

Controlled diet first

EXPERIMENTAL

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).

Drug: Sodium bicarbonateOther: Controlled diet

Sodium bicarbonate first

EXPERIMENTAL

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).

Drug: Sodium bicarbonateOther: Controlled diet

Interventions

Sodium bicarbonateDRUG

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

Also known as: Baking powder
Controlled diet firstSodium bicarbonate first
Controlled dietOTHER

Diet without sodium bicarbonate supplementation

Controlled diet firstSodium bicarbonate first

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 33810868DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Diseases

Interventions

Sodium Bicarbonatebaking powder

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Julia Scialla

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

April 1, 2015

Primary Completion

August 25, 2017

Study Completion

August 25, 2017

Last Updated

August 30, 2017

Record last verified: 2017-04

Locations

US(1)