NCT02743650

Brief Summary

The goal of this pilot study is to determine whether oral sodium bicarbonate can raise low serum bicarbonate concentration in people without chronic kidney disease (CKD). Participants will take sodium bicarbonate for six weeks, followed by a four week washout period.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

April 6, 2016

Last Update Submit

November 11, 2018

Conditions

Chronic Kidney Disease

Keywords

Low Serum Bicarbonate LevelSodium Bicarbonate

Outcome Measures

Primary Outcomes (1)

  • Change in serum bicarbonate concentration from baseline to 6 weeks

    Comparison of pre-intervention serum bicarbonate levels to week 6 levels following treatment with oral sodium bicarbonate.

    Baseline and 6 weeks

Secondary Outcomes (1)

  • Change in serum bicarbonate concentration after 4 weeks of stopping sodium bicarbonate treatment

    Baseline, 6 weeks and 10 weeks

Study Arms (1)

Sodium Bicarbonate

EXPERIMENTAL

All participants will receive oral sodium bicarbonate for 6 weeks (On-treatment period). After the 6 week visit, participants will stop taking sodium bicarbonate and return for a final visit 4 weeks later (Off-treatment period). The initial dose of sodium bicarbonate prescribed is 0.3 mEq/kg/d. If a subject meets the protocol criteria, the dose will be increased to 0.6 mEq/kg/d. Half the dose will be taken by mouth in the morning and the other half in the evening.

Dietary Supplement: Sodium bicarbonate

Interventions

Sodium bicarbonateDIETARY_SUPPLEMENT

The initial dose of sodium bicarbonate is 0.3 mEq/kg/d. If a subject meets the protocol criteria, the dose will be increased to 0.6 mEq/kg/d.

Sodium Bicarbonate

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m2
  • Urinary albumin/creatinine ratio \< 30 mg/gm
  • Serum bicarbonate ≤ 23 mEq/L (average of the two most recent measurements within the past year)
  • Age ≥ 50 years

You may not qualify if:

  • Blood pressure ≥ 160/100 mm Hg
  • Serum potassium \< 3.5 mEq/L
  • New York Heart Association Class 3 or 4 heart failure symptoms
  • Chronic oxygen therapy
  • Chronic obstructive pulmonary disease requiring daily bronchodilator or prednisone therapy
  • Weight ≥ 160 kg
  • Use of sodium bicarbonate, sodium citrate, potassium citrate, or potassium bicarbonate within the previous two weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Salt Lake City Healthcare System

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

  • Goldenstein L, Driver TH, Fried LF, Rifkin DE, Patel KV, Yenchek RH, Harris TB, Kritchevsky SB, Newman AB, Sarnak MJ, Shlipak MG, Ix JH; Health ABC Study Investigators. Serum bicarbonate concentrations and kidney disease progression in community-living elders: the Health, Aging, and Body Composition (Health ABC) Study. Am J Kidney Dis. 2014 Oct;64(4):542-9. doi: 10.1053/j.ajkd.2014.05.009. Epub 2014 Jun 18.

    PMID: 24953890BACKGROUND

  • Driver TH, Shlipak MG, Katz R, Goldenstein L, Sarnak MJ, Hoofnagle AN, Siscovick DS, Kestenbaum B, de Boer IH, Ix JH. Low serum bicarbonate and kidney function decline: the Multi-Ethnic Study of Atherosclerosis (MESA). Am J Kidney Dis. 2014 Oct;64(4):534-41. doi: 10.1053/j.ajkd.2014.05.008. Epub 2014 Jun 18.

    PMID: 24953891BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic 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

  • Kalani L Raphael, MD

    VA Salt Lake City Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 19, 2016

Study Start

February 1, 2016

Primary Completion

June 14, 2017

Study Completion

June 14, 2017

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)