Chronic Kidney DiseaseNCT02743650
Pilot Study of Sodium Bicarbonate in Generally Healthy People With Low Bicarbonate
A study testing Sodium bicarbonate in people with Chronic Kidney Disease, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 14 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Healthcare System
Salt Lake City, Utah, 84112
About this study
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.
Read the detailed description
CKD affects 25 million Americans and the risks of cardiovascular morbidity, hospitalizations, and death are substantially higher for people with CKD. Furthermore, 6% of the total Medicare budget is spent on 600,000 people with end-stage renal disease. Thus, CKD is highly prevalent, associates with poor outcomes, and is a tremendous financial burden to society.
Apart from treating hypertension and diabetes, there are no therapies that prevent CKD. However, results from two studies have found that low serum bicarbonate levels increase risk of developing CKD, which suggests that normalizing low serum bicarbonate may prevent CKD.
One way to raise low serum bicarbonate is by taking sodium bicarbonate. Whether sodium bicarbonate, which is commonly prescribed to raise low serum bicarbonate in people with CKD, can raise low bicarbonate in people without CKD is uncertain because the reason bicarbonate is low in people without CKD is unclear. This is because low bicarbonate by itself cannot distinguish whether the acid-base abnormality is primary metabolic acidosis or respiratory alkalosis. The former process is readily corrected with alkali. However, the administration of alkali in the latter situation may not raise bicarbonate concentration.
Therefore, the purpose of this pilot study is to determine whether oral sodium bicarbonate can raise low serum bicarbonate in people without renal disease.
The study is a single-arm open label study of 15 individuals without CKD with low serum bicarbonate concentration. The study duration is 10 weeks. After completing the baseline visit, participants will take oral sodium bicarbonate (initial dose level: 0.3 milliequivalents per kilogram per day (mEq/kg/d) for 6 weeks (On-treatment period), followed by a 4 week Off-treatment period. Serum concentrations of sodium bicarbonate will be tested during the treatment period, at the end of the On-treatment period (Week 6) and at the end of the Off-treatment period (Week 10).
- Conditions
- Chronic Kidney Disease
- Being tested
- Sodium bicarbonate
- Keywords
- Low Serum Bicarbonate Level, Sodium Bicarbonate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Change in serum bicarbonate concentration after 4 weeks of stopping sodium bicarbonate treatment
Comparison of serum bicarbonate levels four weeks after discontinuing oral sodium bicarbonate treatment to pre-intervention (baseline) and immediate post-treatment (week 6) serum bicarbonate levels.
Measured: Baseline, 6 weeks and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Why it stopped: Difficulties identifying subjects who were qualified to participate in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Utah Center on Aging
- Responsible party
- Principal investigator, Kalani Raphael, University of Utah
- Investigators
- Kalani L Raphael, MD, Principal investigator, VA Salt Lake City Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743650
- Sponsor's protocol ID
- 81006
- Status last verified
- Nov 2018
- First submitted
- 6 Apr 2016
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24953890Driver 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.
PubMed 24953891
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Sodium Bicarbonate in Generally Healthy People With Low Bicarbonate
- ClinicalTrials.gov ID
- NCT02743650
- Acronym / sponsor ID
- 81006
- Conditions
- Chronic Kidney Disease
- Keywords
- Low Serum Bicarbonate Level, Sodium Bicarbonate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties identifying subjects who were qualified to participate in the study
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- The University of Utah Center on Aging
- Study start
- Feb 2016
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CKD affects 25 million Americans and the risks of cardiovascular morbidity, hospitalizations, and death are substantially higher for people with CKD. Furthermore, 6% of the total Medicare budget is spent on 600,000 people with end-stage renal disease. Thus, CKD is highly prevalent, associates with poor outcomes, and is a tremendous financial burden to society.
Apart from treating hypertension and diabetes, there are no therapies that prevent CKD. However, results from two studies have found that low serum bicarbonate levels increase risk of developing CKD, which suggests that normalizing low serum bicarbonate may prevent CKD.
One way to raise low serum bicarbonate is by taking sodium bicarbonate. Whether sodium bicarbonate, which is commonly prescribed to raise low serum bicarbonate in people with CKD, can raise low bicarbonate in people without CKD is uncertain because the reason bicarbonate is low in people without CKD is unclear. This is because low bicarbonate by itself cannot distinguish whether the acid-base abnormality is primary metabolic acidosis or respiratory alkalosis. The former process is readily corrected with alkali. However, the administration of alkali in the latter situation may not raise bicarbonate concentration.
Therefore, the purpose of this pilot study is to determine whether oral sodium bicarbonate can raise low serum bicarbonate in people without renal disease.
The study is a single-arm open label study of 15 individuals without CKD with low serum bicarbonate concentration. The study duration is 10 weeks. After completing the baseline visit, participants will take oral sodium bicarbonate (initial dose level: 0.3 milliequivalents per kilogram per day (mEq/kg/d) for 6 weeks (On-treatment period), followed by a 4 week Off-treatment period. Serum concentrations of sodium bicarbonate will be tested during the treatment period, at the end of the On-treatment period (Week 6) and at the end of the Off-treatment period (Week 10).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate | Experimental | Dietary Supplement: Sodium bicarbonateAll 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateThe 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. | Dietary supplement | Sodium Bicarbonate |
Primary outcome
Change in serum bicarbonate concentration from baseline to 6 weeks
Time frame: Baseline and 6 weeks
Comparison of pre-intervention serum bicarbonate levels to week 6 levels following treatment with oral sodium bicarbonate.
1 secondary outcome
Change in serum bicarbonate concentration after 4 weeks of stopping sodium bicarbonate treatment
Time frame: Baseline, 6 weeks and 10 weeks
Results and safety
The study was stopped early (reason given: Difficulties identifying subjects who were qualified to participate in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Background: PubMed 24953890Goldenstein 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.
- Background: PubMed 24953891Driver 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalani L Raphael, MD principal investigator
VA Salt Lake City Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate in people with Chronic Kidney Disease, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties identifying subjects who were qualified to participate in the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum bicarbonate concentration from baseline to 6 weeks (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743650, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.