Chronic Kidney Disease, Disability
Conditions
Keywords
Geriatric, bicarbonate
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTOral bicarbonate supplementation
DIETARY_SUPPLEMENTPlacebo
Sponsors
National Institute on Aging (NIA)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Bicarbonate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Adherence: Percentage of Pills Taken | 6 months post baseline | based on pill count |
| Percentage of Screened Participants Randomized | baseline | The number of participants randomized divided by the number of participants screened. Count of participants reflects the number of participants randomized. |
| Carbon Dioxide Blood Test | baseline | Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L) |
| 400 Meter Walk Time | baseline | — |
| Estimated Glomerular Filtration Rate (eGFR) | 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 |
| Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline | six 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 |
| Hip Bone Mineral Density | baseline | Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment. |
| Femoral Neck Bone Mineral Density | baseline | Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment. |
| Average Body Mass Index (BMI) | baseline | — |
| Urinary Albumin to Creatinine Ratio (ACR) | baseline | 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. |
| Measurement of Kidney Function (eGFR) at Baseline. | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Net Endogenous Acid Production (NEAP) | 6 months post randomization | (mEq/day) by the kidney |
Countries
United States
Participant flow
Recruitment details
196 subjects signed consent; all except 83 were screen failures; 83 subjects were randomized
Participants by arm
| Arm | Count |
|---|---|
| Oral Bicarbonate Supplementation Group 0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation | 41 |
| Placebo Group Methylcellulose capsules
Placebo | 42 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Screen failure after baseline | 2 | 2 |
| Overall Study | withdrawn after Follow up 1 visit | 2 | 2 |
| Overall Study | Withdrawn after Follow up 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo Group | Total | Oral Bicarbonate Supplementation Group |
|---|---|---|---|
| Age, Continuous | 72.3 years STANDARD_DEVIATION 5.5 | 72.8 years STANDARD_DEVIATION 5.7 | 73.3 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 81 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 73 Participants | 36 Participants |
| Sex: Female, Male Female | 25 Participants | 49 Participants | 24 Participants |
| Sex: Female, Male Male | 17 Participants | 34 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 42 |
| other Total, other adverse events | 8 / 41 | 8 / 42 |
| serious Total, serious adverse events | 1 / 41 | 1 / 42 |
Outcome results
Primary
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
Population: PI is reporting blood bicarbonate from blood gas measurement as a surrogate of NEA because a percentage of NEA samples could not be accurately measured due to technical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Blood Bicarbonate | 22.8 mmol/L | Standard Deviation 2.3 |
| Placebo Group | Blood Bicarbonate | 23.2 mmol/L | Standard Deviation 2.4 |
Primary
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
Population: PI is reporting blood bicarbonate from blood gas measurement as a surrogate of NEA because a percentage of NEA samples could not be accurately measured due to technical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Blood Bicarbonate | 23.8 mmol/L | Standard Deviation 2.3 |
| Placebo Group | Blood Bicarbonate | 23.3 mmol/L | Standard Deviation 2.1 |
Secondary
400 Meter Walk Time
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | 400 Meter Walk Time | 6.3 minutes | Standard Deviation 1.2 |
| Placebo Group | 400 Meter Walk Time | 6.3 minutes | Standard Deviation 1.4 |
Secondary
400 Meter Walk Time
Time frame: three months post baseline
Population: 1 bicarb Participant refused 400m walk at the 3-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | 400 Meter Walk Time | 6.3 minutes | Standard Deviation 1 |
| Placebo Group | 400 Meter Walk Time | 6.5 minutes | Standard Deviation 1.7 |
Secondary
400 Meter Walk Time
Time frame: six months post baseline
Population: 3 participants (2 bicarb and 1 placebo) refused 400m walk at the 6-month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | 400 Meter Walk Time | 6.1 minutes | Standard Deviation 1 |
| Placebo Group | 400 Meter Walk Time | 6.3 minutes | Standard Deviation 1.5 |
Secondary
Average Body Mass Index (BMI)
Time frame: baseline
Population: baseline BMI is missing for 4 participants (3 bicarb and 1 placebo) due to missing height measurement (height was only measured at the screening visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Average Body Mass Index (BMI) | 27.6 kg/m^2 | Standard Deviation 5.3 |
| Placebo Group | Average Body Mass Index (BMI) | 28.1 kg/m^2 | Standard Deviation 4.8 |
Secondary
Average Body Mass Index (BMI)
Time frame: six months post baseline
Population: 6-month BMI is missing for 4 participants (3 bicarb and 1 placebo) due to missing height measurement (height was only measured at the screening visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Average Body Mass Index (BMI) | 26.3 kg/m^2 | Standard Deviation 4.4 |
| Placebo Group | Average Body Mass Index (BMI) | 28.1 kg/m^2 | Standard Deviation 4.9 |
Secondary
Average Body Mass Index (BMI)
Time frame: three months post baseline
Population: 3-month BMI is missing for 4 participants (3 bicarb and 1 placebo) due to missing height measurement (height was only measured at the screening visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Average Body Mass Index (BMI) | 26.6 kg/m^2 | Standard Deviation 4.4 |
| Placebo Group | Average Body Mass Index (BMI) | 28.3 kg/m^2 | Standard Deviation 4.9 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Carbon Dioxide Blood Test | 36.9 mEq/L | Standard Deviation 3.9 |
| Placebo Group | Carbon Dioxide Blood Test | 37.0 mEq/L | Standard Deviation 3.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Carbon Dioxide Blood Test | 35.4 mEq/L | Standard Deviation 3.6 |
| Placebo Group | Carbon Dioxide Blood Test | 36.5 mEq/L | Standard Deviation 4.1 |
Secondary
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
Population: creatinine and MDRD equation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Estimated Glomerular Filtration Rate (eGFR) | 65.4 mL/min/1.73m^2 | Standard Deviation 13.1 |
| Placebo Group | Estimated Glomerular Filtration Rate (eGFR) | 66.9 mL/min/1.73m^2 | Standard Deviation 15.1 |
Secondary
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
Population: creatinine and MDRD equation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Estimated Glomerular Filtration Rate (eGFR) | 64.7 mL/min/1.73m^2 | Standard Deviation 16 |
| Placebo Group | Estimated Glomerular Filtration Rate (eGFR) | 64.7 mL/min/1.73m^2 | Standard Deviation 17.8 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Estimated Glomerular Filtration Rate (eGFR) | 66 mL/min/1.73m^2 | Standard Deviation 15.3 |
| Placebo Group | Estimated Glomerular Filtration Rate (eGFR) | 63.9 mL/min/1.73m^2 | Standard Deviation 15.7 |
Secondary
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
Population: cystatin C and CKD Epi equation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline | 80.1 mL/min/1.73m^2 | Standard Deviation 20.3 |
| Placebo Group | Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline | 81.0 mL/min/1.73m^2 | Standard Deviation 20.4 |
Secondary
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
Population: No baseline DXA scans were completed for 3 bicarb and 1 placebo participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Femoral Neck Bone Mineral Density | .76 g/cm^3 | Standard Deviation 0.13 |
| Placebo Group | Femoral Neck Bone Mineral Density | .74 g/cm^3 | Standard Deviation 0.15 |
Secondary
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
Population: No 6-month DXA scans were completed for 1 bicarb and 3 placebo participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Femoral Neck Bone Mineral Density | .74 g/cm^3 | Standard Deviation 0.13 |
| Placebo Group | Femoral Neck Bone Mineral Density | .72 g/cm^3 | Standard Deviation 0.14 |
Secondary
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
Population: No baseline dual energy x-ray absorptiometry (DXA) scans were completed for 3 bicarb and 1 placebo participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Hip Bone Mineral Density | .94 g/cm^3 | Standard Deviation 0.15 |
| Placebo Group | Hip Bone Mineral Density | .93 g/cm^3 | Standard Deviation 0.18 |
Secondary
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
Population: No 6-month DXA scans were completed for 1 bicarb and 3 placebo participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Hip Bone Mineral Density | .93 g/cm^3 | Standard Deviation 0.15 |
| Placebo Group | Hip Bone Mineral Density | .91 g/cm^3 | Standard Deviation 0.15 |
Secondary
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
Population: cystatin C and CKD Epi equation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Measurement of Kidney Function (eGFR) at Baseline. | 81.3 mL/min/1.73m^2 | Standard Deviation 19.1 |
| Placebo Group | Measurement of Kidney Function (eGFR) at Baseline. | 81.3 mL/min/1.73m^2 | Standard Deviation 21 |
Secondary
Percent Adherence: Percentage of Pills Taken
based on pill count
Time frame: 6 months post baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Percent Adherence: Percentage of Pills Taken | 90.5 percentage of pills | Standard Deviation 12.9 |
| Placebo Group | Percent Adherence: Percentage of Pills Taken | 85.2 percentage of pills | Standard Deviation 21.4 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Bicarbonate Supplementation Group | Percentage of Screened Participants Randomized | 83 Participants |
Secondary
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
Population: 3-month ACR is missing for 10 participants (5 bicarb and 5 placebo).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Urinary Albumin to Creatinine Ratio (ACR) | 33.9 mg/g | Standard Deviation 40.3 |
| Placebo Group | Urinary Albumin to Creatinine Ratio (ACR) | 52.8 mg/g | Standard Deviation 126 |
Secondary
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
Population: baseline ACR is missing for 7 participants (3 bicarb and 4 placebo).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Urinary Albumin to Creatinine Ratio (ACR) | 25.1 mg/g | Standard Deviation 23.2 |
| Placebo Group | Urinary Albumin to Creatinine Ratio (ACR) | 53.8 mg/g | Standard Deviation 139.7 |
Secondary
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
Population: 6-month ACR is missing for 5 participants (0 bicarb and 5 placebo).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Urinary Albumin to Creatinine Ratio (ACR) | 45.1 mg/g | Standard Deviation 119.8 |
| Placebo Group | Urinary Albumin to Creatinine Ratio (ACR) | 80.4 mg/g | Standard Deviation 254.7 |
Other Pre-specified
Net Endogenous Acid Production (NEAP)
(mEq/day) by the kidney
Time frame: 6 months post randomization
Population: 6 month data missing for one subject in bicarbonate (bicarb) arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Net Endogenous Acid Production (NEAP) | 75.0 mEq/day | Standard Deviation 37.6 |
| Placebo Group | Net Endogenous Acid Production (NEAP) | 73.8 mEq/day | Standard Deviation 39 |
Other Pre-specified
Net Endogenous Acid Production (NEAP)
mEq/day by the kidney
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Net Endogenous Acid Production (NEAP) | 79.3 mEq/day | Standard Deviation 29.7 |
| Placebo Group | Net Endogenous Acid Production (NEAP) | 72.1 mEq/day | Standard Deviation 23.4 |
Other Pre-specified
Net Endogenous Acid Production (NEAP)
mEq/day by the kidney
Time frame: 3 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Bicarbonate Supplementation Group | Net Endogenous Acid Production (NEAP) | 79.4 mEq/day | Standard Deviation 33.2 |
| Placebo Group | Net Endogenous Acid Production (NEAP) | 75.3 mEq/day | Standard Deviation 38.7 |