Chronic Kidney DiseaseBICARBNCT02691663
Dietary Acid Load, Kidney Function and Disability in Elderly
A study testing Oral bicarbonate supplementation in people with Chronic Kidney Disease and Disability, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effect of a bicarbonate supplement on kidney function and physical function. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Kidney Disease, Disability
- What is being tested?
- Oral bicarbonate supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 +years of age
- Short physical performance battery (SPPB) score>3
- Estimated glomerular filtration rate (eGFR) 30-89
- Net endogenous acid production (NEAP) >=40 mEq/d
- Willing to provide informed consent and agrees to randomization
- Not involved in another intervention study
Who cannot join
- Uncontrolled (>160 mg/dl fasting blood glucose), insulin-dependent diabetes and/or uncontrolled hypertension (Systolic Blood Pressure >160, Diastolic BP>100)
- a current diagnosis of psychotic disorder
- take more than 14 alcoholic drinks per week
- plan to relocate out of the study area within the next year
- self-reported inability to walk across a room
- those who reside in nursing homes
Show all 21Show fewer
- have difficulty communicating with study personnel due to speech or language or hearing problems
- had cancer requiring treatment in the past 1 year
- lung disease requiring regular use of corticosteroids or of supplemental oxygen
- cardiovascular disease (Class III or IV congestive heart failure)
- significant valvular disease, uncontrolled angina
- myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery) in past 6 months
- stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months, Parkinson's disease or other progressive neurological disorder
- other medical or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention
- clinical judgment concerning safety or noncompliance
- Individuals with BMI <18.5; or weight loss >4% in last 6 months
- Montreal Cognitive Assessment (MoCA) score under 24
- End Stage Renal Disease (ESRD) on dialysis or primary kidney disease
- Other illness of such severity that life expectancy is less than 12 months
- Smoking; defined as not smoking for more than a year prior to the study
- Serum Bicarbonate (HCO3)>30 milliequivalents per liter (mEq/L); serum potassium out of normal range
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
The purpose of this research study is to determine the effect of a bicarbonate supplement on kidney function and physical function.
Read the detailed description
Physical decline and frailty result from age- and disease-related impairments in organs and tissues. Frailty research has focused on the musculoskeletal, neurological and circulatory systems; yet interventions targeting these systems had limited success in preventing and treating functional decline. Given the aging of the US population, additional avenues for intervention development are urgently needed. Fragility and disability in people ≥65 strongly correlate with declining kidney function and are evident even in early stages of chronic kidney disease (CKD). Moreover, CKD is highly prevalent in the elderly and associates with sarcopenia, osteopenia, and increased incidence of fractures/falls with hospitalization. Low serum bicarbonate and impaired acid-base homeostasis, also common in CKD, are increasingly appreciated as contributors to functional decline with advancing age. With aging, the adaptive response of the kidney to low serum bicarbonate and high metabolic acid load becomes maladaptive, facilitating CKD progression. Conversely, in adult patients with CKD, maintenance of serum bicarbonate at 24 meq/L with oral bicarbonate supplementation or increased consumption of base-forming foods slows CKD progression.
The study investigators propose the current study and protocol based on the evidence summarized above and our preliminary studies, which suggest that: In the Health Aging and Body Composition cohort (age 70-79) lower dietary acid load associates with stable kidney function over a 7-year follow-up, independent of age, race, gender, BMI, diabetes, hypertension or smoking status; metabolomics analysis in participants of the African American Diabetes Heart Study suggested that it is feasible to segregate a urine metabolomics profile in the early stages of CKD (stages 2 and 3), and that lower consumption of base-forming fruits and vegetables and higher rates of acid excretion may be associated with CKD and its progression.
The investigators therefore hypothesized that decreasing metabolic acid production by titrating dietary acid load may ameliorate the generally expected, age-related decline in kidney function, decrease loss of lean body mass, preserve physical function, and ameliorate disability. This is not a treatment study as the investigators are exploring the effects of bicarbonate on these age-related issues.
- Conditions
- Chronic Kidney Disease, Disability
- Being tested
- Oral bicarbonate supplementation, Placebo
- Keywords
- Geriatric, 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.
Oral bicarbonate supplementationDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Oral bicarbonate supplementation group | Active comparator | 0.3 meq/kg/day NaHCO3 capsules Receives: Dietary Supplement: Oral bicarbonate supplementation |
| Placebo group | Placebo comparator | Methylcellulose capsules Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Bicarbonate
measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults
Measured: baseline
Blood Bicarbonate
measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults
Measured: six months post baseline
Secondary outcomes (22)
Percentage of Screened Participants Randomized
The number of participants randomized divided by the number of participants screened. Count of participants reflects the number of participants randomized.
Measured: baseline
Percent Adherence: Percentage of Pills Taken
based on pill count
Measured: 6 months post baseline
Carbon Dioxide Blood Test
Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)
Measured: baseline
Carbon Dioxide Blood Test
Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)
Measured: six months post baseline
400 Meter Walk Time
Measured: baseline
400 Meter Walk Time
Measured: three months post baseline
400 Meter Walk Time
Measured: six months post baseline
Estimated Glomerular Filtration Rate (eGFR)
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Measured: baseline
Estimated Glomerular Filtration Rate (eGFR)
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Measured: three months post baseline
Estimated Glomerular Filtration Rate (eGFR)
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Measured: six months post baseline
Measurement of Kidney Function (eGFR) at Baseline.
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Measured: baseline
Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Measured: six months post baseline
Hip Bone Mineral Density
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Measured: baseline
Hip Bone Mineral Density
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Measured: six months post baseline
Femoral Neck Bone Mineral Density
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Measured: baseline
Femoral Neck Bone Mineral Density
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Measured: six months post baseline
Average Body Mass Index (BMI)
Measured: baseline
Average Body Mass Index (BMI)
Measured: three months post baseline
Average Body Mass Index (BMI)
Measured: six months post baseline
Urinary Albumin to Creatinine Ratio (ACR)
The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.
Measured: baseline
Urinary Albumin to Creatinine Ratio (ACR)
The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.
Measured: three months post baseline
Urinary Albumin to Creatinine Ratio (ACR)
The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.
Measured: six months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Snezana Petrovic, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691663
- Sponsor's protocol ID
- IRB00034474
- Other IDs
- R21AG051866
- Acronym
- BICARB
- Status last verified
- Jun 2023
- First submitted
- 22 Feb 2016
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Acid Load, Kidney Function and Disability in Elderly
- ClinicalTrials.gov ID
- NCT02691663
- Acronym / sponsor ID
- BICARB / IRB00034474
- Conditions
- Chronic Kidney Disease, Disability
- Keywords
- Geriatric, bicarbonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Feb 2016 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Posted 25 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine the effect of a bicarbonate supplement on kidney function and physical function.
Detailed description
Physical decline and frailty result from age- and disease-related impairments in organs and tissues. Frailty research has focused on the musculoskeletal, neurological and circulatory systems; yet interventions targeting these systems had limited success in preventing and treating functional decline. Given the aging of the US population, additional avenues for intervention development are urgently needed. Fragility and disability in people ≥65 strongly correlate with declining kidney function and are evident even in early stages of chronic kidney disease (CKD). Moreover, CKD is highly prevalent in the elderly and associates with sarcopenia, osteopenia, and increased incidence of fractures/falls with hospitalization. Low serum bicarbonate and impaired acid-base homeostasis, also common in CKD, are increasingly appreciated as contributors to functional decline with advancing age. With aging, the adaptive response of the kidney to low serum bicarbonate and high metabolic acid load becomes maladaptive, facilitating CKD progression. Conversely, in adult patients with CKD, maintenance of serum bicarbonate at 24 meq/L with oral bicarbonate supplementation or increased consumption of base-forming foods slows CKD progression.
The study investigators propose the current study and protocol based on the evidence summarized above and our preliminary studies, which suggest that: In the Health Aging and Body Composition cohort (age 70-79) lower dietary acid load associates with stable kidney function over a 7-year follow-up, independent of age, race, gender, BMI, diabetes, hypertension or smoking status; metabolomics analysis in participants of the African American Diabetes Heart Study suggested that it is feasible to segregate a urine metabolomics profile in the early stages of CKD (stages 2 and 3), and that lower consumption of base-forming fruits and vegetables and higher rates of acid excretion may be associated with CKD and its progression.
The investigators therefore hypothesized that decreasing metabolic acid production by titrating dietary acid load may ameliorate the generally expected, age-related decline in kidney function, decrease loss of lean body mass, preserve physical function, and ameliorate disability. This is not a treatment study as the investigators are exploring the effects of bicarbonate on these age-related issues.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral bicarbonate supplementation group | Active comparator | Dietary Supplement: Oral bicarbonate supplementation0.3 meq/kg/day NaHCO3 capsules |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboMethylcellulose capsules |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 +years of age
- Short physical performance battery (SPPB) score>3
- Estimated glomerular filtration rate (eGFR) 30-89
- Net endogenous acid production (NEAP) >=40 mEq/d
- Willing to provide informed consent and agrees to randomization
Key exclusion criteria (21 listed)
- Uncontrolled (>160 mg/dl fasting blood glucose), insulin-dependent diabetes and/or uncontrolled hypertension (Systolic Blood Pressure >160, Diastolic BP>100)
- a current diagnosis of psychotic disorder
- take more than 14 alcoholic drinks per week
- plan to relocate out of the study area within the next year
- self-reported inability to walk across a room
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 |
|---|---|---|
| Oral bicarbonate supplementation | Dietary supplement | Oral bicarbonate supplementation group |
| Placebo | Dietary supplement | Placebo group |
Primary outcome
Blood Bicarbonate
Time frame: baseline
measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults
Blood Bicarbonate
Time frame: six months post baseline
measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults
22 secondary outcomes
Percentage of Screened Participants Randomized
Time frame: baseline
Percent Adherence: Percentage of Pills Taken
Time frame: 6 months post baseline
Carbon Dioxide Blood Test
Time frame: baseline
Carbon Dioxide Blood Test
Time frame: six months post baseline
400 Meter Walk Time
Time frame: baseline
400 Meter Walk Time
Time frame: three months post baseline
400 Meter Walk Time
Time frame: six months post baseline
Estimated Glomerular Filtration Rate (eGFR)
Time frame: baseline
Estimated Glomerular Filtration Rate (eGFR)
Time frame: three months post baseline
Estimated Glomerular Filtration Rate (eGFR)
Time frame: six months post baseline
Measurement of Kidney Function (eGFR) at Baseline.
Time frame: baseline
Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline
Time frame: six months post baseline
Hip Bone Mineral Density
Time frame: baseline
Hip Bone Mineral Density
Time frame: six months post baseline
Femoral Neck Bone Mineral Density
Time frame: baseline
Femoral Neck Bone Mineral Density
Time frame: six months post baseline
Average Body Mass Index (BMI)
Time frame: baseline
Average Body Mass Index (BMI)
Time frame: three months post baseline
Average Body Mass Index (BMI)
Time frame: six months post baseline
Urinary Albumin to Creatinine Ratio (ACR)
Time frame: baseline
Urinary Albumin to Creatinine Ratio (ACR)
Time frame: three months post baseline
Urinary Albumin to Creatinine Ratio (ACR)
Time frame: six months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Snezana Petrovic, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral bicarbonate supplementation in people with Chronic Kidney Disease and Disability, run by Wake Forest University Health Sciences 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 6 inclusion and 21 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: finished, as of the sponsor's last update on 25 Sep 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Bicarbonate (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2023.