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CompletedNCT02691663BICARBUpdated Sep 25, 2023Results posted

Dietary Acid Load, Kidney Function and Disability in Elderly

An interventional study of Oral bicarbonate supplementation and Placebo in Chronic Kidney Disease and Disability, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Kidney Disease
  • Disability

Keywords

  • Geriatric
  • bicarbonate
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 196 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
196 participants (actual)

Study arms

  • Active comparator
    Oral bicarbonate supplementation group

    0.3 meq/kg/day NaHCO3 capsules

    Dietary Supplement: Oral bicarbonate supplementation

  • Placebo comparator
    Placebo group

    Methylcellulose capsules

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementOral bicarbonate supplementation
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

  2. 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

    Time frame: six months post baseline

Secondary outcomes

  1. 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.

    Time frame: baseline

  2. Percent Adherence: Percentage of Pills Taken

    based on pill count

    Time frame: 6 months post baseline

  3. Carbon Dioxide Blood Test

    Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)

    Time frame: baseline

  4. Carbon Dioxide Blood Test

    Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)

    Time frame: six months post baseline

  5. 400 Meter Walk Time

    Time frame: baseline

  6. 400 Meter Walk Time

    Time frame: three months post baseline

  7. 400 Meter Walk Time

    Time frame: six months post baseline

  8. 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

    Time frame: baseline

  9. 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

    Time frame: three months post baseline

  10. 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

    Time frame: six months post baseline

  11. 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

    Time frame: baseline

  12. 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

    Time frame: six months post baseline

  13. 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.

    Time frame: baseline

  14. 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.

    Time frame: six months post baseline

  15. 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.

    Time frame: baseline

  16. 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.

    Time frame: six months post baseline

  17. Average Body Mass Index (BMI)

    Time frame: baseline

  18. Average Body Mass Index (BMI)

    Time frame: three months post baseline

  19. Average Body Mass Index (BMI)

    Time frame: six months post baseline

  20. 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.

    Time frame: baseline

  21. 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.

    Time frame: three months post baseline

  22. 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.

    Time frame: six months post baseline

Other outcomes

  1. Net Endogenous Acid Production (NEAP)

    (mEq/day) by the kidney

    Time frame: 6 months post randomization

  2. Net Endogenous Acid Production (NEAP)

    mEq/day by the kidney

    Time frame: 3 months post randomization

  3. Net Endogenous Acid Production (NEAP)

    mEq/day by the kidney

    Time frame: Baseline

07

Results

Posted Sep 25, 2023

Participant flow

196 subjects signed consent; all except 83 were screen failures; 83 subjects were randomized

Participant flow — Overall Study
MilestoneOral Bicarbonate Supplementation GroupPlacebo Group
Started4142
Completed3335
Not completed87
Withdrew: Screen failure after baseline22
Withdrew: Withdrawn after follow up 1 visit22
Withdrew: Withdrawn after follow up 211
Withdrew: Lost to follow-up32

Outcome measures

PrimaryBlood 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

Time frame:
baseline
Reported as:
Mean · mmol/L
Blood Bicarbonate
mmol/LOral Bicarbonate Supplementation GroupPlacebo Group
Blood Bicarbonate22.8 ± 2.323.2 ± 2.4
PrimaryBlood 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

Time frame:
six months post baseline
Reported as:
Mean · mmol/L
Blood Bicarbonate
mmol/LOral Bicarbonate Supplementation GroupPlacebo Group
Blood Bicarbonate23.8 ± 2.323.3 ± 2.1
SecondaryPercentage 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.

Time frame:
baseline
Reported as:
Count of participants · Participants
Percentage of Screened Participants Randomized
ParticipantsOverall Study
Percentage of Screened Participants Randomized83
SecondaryPercent Adherence: Percentage of Pills Taken

based on pill count

Time frame:
6 months post baseline
Reported as:
Mean · percentage of pills
Percent Adherence: Percentage of Pills Taken
percentage of pillsOral Bicarbonate Supplementation GroupPlacebo Group
Percent Adherence: Percentage of Pills Taken90.5 ± 12.985.2 ± 21.4
SecondaryCarbon Dioxide Blood Test

Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)

Time frame:
baseline
Reported as:
Mean · mEq/L
Carbon Dioxide Blood Test
mEq/LOral Bicarbonate Supplementation GroupPlacebo Group
Carbon Dioxide Blood Test35.4 ± 3.636.5 ± 4.1
SecondaryCarbon Dioxide Blood Test

Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)

Time frame:
six months post baseline
Reported as:
Mean · mEq/L
Carbon Dioxide Blood Test
mEq/LOral Bicarbonate Supplementation GroupPlacebo Group
Carbon Dioxide Blood Test36.9 ± 3.937.0 ± 3.5
Secondary400 Meter Walk Time
Time frame:
baseline
Reported as:
Mean · minutes
400 Meter Walk Time
minutesOral Bicarbonate Supplementation GroupPlacebo Group
400 Meter Walk Time6.3 ± 1.26.3 ± 1.4
Secondary400 Meter Walk Time
Time frame:
three months post baseline
Reported as:
Mean · minutes
400 Meter Walk Time
minutesOral Bicarbonate Supplementation GroupPlacebo Group
400 Meter Walk Time6.3 ± 1.06.5 ± 1.7
Secondary400 Meter Walk Time
Time frame:
six months post baseline
Reported as:
Mean · minutes
400 Meter Walk Time
minutesOral Bicarbonate Supplementation GroupPlacebo Group
400 Meter Walk Time6.1 ± 1.06.3 ± 1.5
SecondaryEstimated 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

Time frame:
baseline
Reported as:
Mean · mL/min/1.73m^2
Estimated Glomerular Filtration Rate (eGFR)
mL/min/1.73m^2Oral Bicarbonate Supplementation GroupPlacebo Group
Estimated Glomerular Filtration Rate (eGFR)65.4 ± 13.166.9 ± 15.1
SecondaryEstimated 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

Time frame:
three months post baseline
Reported as:
Mean · mL/min/1.73m^2
Estimated Glomerular Filtration Rate (eGFR)
mL/min/1.73m^2Oral Bicarbonate Supplementation GroupPlacebo Group
Estimated Glomerular Filtration Rate (eGFR)66 ± 15.363.9 ± 15.7
SecondaryEstimated 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

Time frame:
six months post baseline
Reported as:
Mean · mL/min/1.73m^2
Estimated Glomerular Filtration Rate (eGFR)
mL/min/1.73m^2Oral Bicarbonate Supplementation GroupPlacebo Group
Estimated Glomerular Filtration Rate (eGFR)64.7 ± 16.064.7 ± 17.8
SecondaryMeasurement 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

Time frame:
baseline
Reported as:
Mean · mL/min/1.73m^2
Measurement of Kidney Function (eGFR) at Baseline.
mL/min/1.73m^2Oral Bicarbonate Supplementation GroupPlacebo Group
Measurement of Kidney Function (eGFR) at Baseline.81.3 ± 19.181.3 ± 21.0
SecondaryEstimated 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

Time frame:
six months post baseline
Reported as:
Mean · mL/min/1.73m^2
Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline
mL/min/1.73m^2Oral Bicarbonate Supplementation GroupPlacebo Group
Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline80.1 ± 20.381.0 ± 20.4
SecondaryHip Bone Mineral Density

Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.

Time frame:
baseline
Reported as:
Mean · g/cm^3
Hip Bone Mineral Density
g/cm^3Oral Bicarbonate Supplementation GroupPlacebo Group
Hip Bone Mineral Density.94 ± .15.93 ± .18
SecondaryHip Bone Mineral Density

Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.

Time frame:
six months post baseline
Reported as:
Mean · g/cm^3
Hip Bone Mineral Density
g/cm^3Oral Bicarbonate Supplementation GroupPlacebo Group
Hip Bone Mineral Density.93 ± .15.91 ± .15
SecondaryFemoral 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.

Time frame:
baseline
Reported as:
Mean · g/cm^3
Femoral Neck Bone Mineral Density
g/cm^3Oral Bicarbonate Supplementation GroupPlacebo Group
Femoral Neck Bone Mineral Density.76 ± .13.74 ± .15
SecondaryFemoral 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.

Time frame:
six months post baseline
Reported as:
Mean · g/cm^3
Femoral Neck Bone Mineral Density
g/cm^3Oral Bicarbonate Supplementation GroupPlacebo Group
Femoral Neck Bone Mineral Density.74 ± .13.72 ± .14
SecondaryAverage Body Mass Index (BMI)
Time frame:
baseline
Reported as:
Mean · kg/m^2
Average Body Mass Index (BMI)
kg/m^2Oral Bicarbonate Supplementation GroupPlacebo Group
Average Body Mass Index (BMI)27.6 ± 5.328.1 ± 4.8
SecondaryAverage Body Mass Index (BMI)
Time frame:
three months post baseline
Reported as:
Mean · kg/m^2
Average Body Mass Index (BMI)
kg/m^2Oral Bicarbonate Supplementation GroupPlacebo Group
Average Body Mass Index (BMI)26.6 ± 4.428.3 ± 4.9
SecondaryAverage Body Mass Index (BMI)
Time frame:
six months post baseline
Reported as:
Mean · kg/m^2
Average Body Mass Index (BMI)
kg/m^2Oral Bicarbonate Supplementation GroupPlacebo Group
Average Body Mass Index (BMI)26.3 ± 4.428.1 ± 4.9
SecondaryUrinary 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.

Time frame:
baseline
Reported as:
Mean · mg/g
Urinary Albumin to Creatinine Ratio (ACR)
mg/gOral Bicarbonate Supplementation GroupPlacebo Group
Urinary Albumin to Creatinine Ratio (ACR)25.1 ± 23.253.8 ± 139.7
SecondaryUrinary 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.

Time frame:
three months post baseline
Reported as:
Mean · mg/g
Urinary Albumin to Creatinine Ratio (ACR)
mg/gOral Bicarbonate Supplementation GroupPlacebo Group
Urinary Albumin to Creatinine Ratio (ACR)33.9 ± 40.352.8 ± 126.0
SecondaryUrinary 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.

Time frame:
six months post baseline
Reported as:
Mean · mg/g
Urinary Albumin to Creatinine Ratio (ACR)
mg/gOral Bicarbonate Supplementation GroupPlacebo Group
Urinary Albumin to Creatinine Ratio (ACR)45.1 ± 119.880.4 ± 254.7
Other pre-specifiedNet Endogenous Acid Production (NEAP)

(mEq/day) by the kidney

Time frame:
6 months post randomization
Reported as:
Mean · mEq/day
Net Endogenous Acid Production (NEAP)
mEq/dayOral Bicarbonate Supplementation GroupPlacebo Group
Net Endogenous Acid Production (NEAP)75.0 ± 37.673.8 ± 39.0
Other pre-specifiedNet Endogenous Acid Production (NEAP)

mEq/day by the kidney

Time frame:
3 months post randomization
Reported as:
Mean · mEq/day
Net Endogenous Acid Production (NEAP)
mEq/dayOral Bicarbonate Supplementation GroupPlacebo Group
Net Endogenous Acid Production (NEAP)79.4 ± 33.275.3 ± 38.7
Other pre-specifiedNet Endogenous Acid Production (NEAP)

mEq/day by the kidney

Time frame:
Baseline
Reported as:
Mean · mEq/day
Net Endogenous Acid Production (NEAP)
mEq/dayOral Bicarbonate Supplementation GroupPlacebo Group
Net Endogenous Acid Production (NEAP)79.3 ± 29.772.1 ± 23.4

Adverse events

Collected over Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oral Bicarbonate Supplementation Group0/41 (0%)1/41 (2.4%)8/41 (19.5%)
Placebo Group0/42 (0%)1/42 (2.4%)8/42 (19%)
Most frequent serious events
Most frequent serious events
EventOral Bicarbonate Supplementation GroupPlacebo Group
Atrial fibrillationCardiac disorders1/410/42
Transient Ischemic AttackNervous system disorders0/411/42
Most frequent other events
Most frequent other events
EventOral Bicarbonate Supplementation GroupPlacebo Group
ConstipationGastrointestinal disorders2/410/42
edemaCardiac disorders2/411/42
indigestionGastrointestinal disorders1/412/42
HeadacheNervous system disorders1/410/42
diarrheaGastrointestinal disorders1/411/42
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders1/410/42
Elevated Blood PressureCardiac disorders0/411/42
atrial fibrillationCardiac disorders0/411/42
VomitingGastrointestinal disorders0/411/42
Broken fifth toe right sideInjury, poisoning and procedural complications0/411/42

Baseline characteristics

Age, Continuous
Age, Continuous(years)Oral Bicarbonate Supplementation GroupPlacebo GroupTotal
Mean73.3 ± 5.972.3 ± 5.572.8 ± 5.7
Sex: Female, Male
Sex: Female, Male(Participants)Oral Bicarbonate Supplementation GroupPlacebo GroupTotal
Female242549
Male171734
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Oral Bicarbonate Supplementation GroupPlacebo GroupTotal
Hispanic or Latino112
Not Hispanic or Latino404181
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Oral Bicarbonate Supplementation GroupPlacebo GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American5510
White363773
More than one race000
Unknown or Not Reported000
08

Study locations

1 site
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02691663
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Feb 25, 2016
Start date
Feb 2016
Primary completion
Jun 15, 2018
Completion
Jun 15, 2018
Results posted
Sep 25, 2023
Last update
Sep 25, 2023

Study contacts

Snezana Petrovic, PhD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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