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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG051866 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this research study is to determine the effect of a bicarbonate supplement on kidney function and physical function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral bicarbonate supplementation group | Active Comparator | 0.3 meq/kg/day NaHCO3 capsules |
|
| Placebo group | Placebo Comparator | Methylcellulose capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral bicarbonate supplementation | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | six months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| Percent Adherence: Percentage of Pills Taken |
| Measure | Description | Time Frame |
|---|---|---|
| Net Endogenous Acid Production (NEAP) | (mEq/day) by the kidney | 6 months post randomization |
| Net Endogenous Acid Production (NEAP) | mEq/day by the kidney |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Snezana Petrovic, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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196 subjects signed consent; all except 83 were screen failures; 83 subjects were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Bicarbonate Supplementation Group | 0.3 meq/kg/day NaHCO3 capsules Oral bicarbonate supplementation |
| FG001 | Placebo Group | Methylcellulose capsules Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Bicarbonate Supplementation Group | 0.3 meq/kg/day NaHCO3 capsules Oral bicarbonate supplementation |
| BG001 | Placebo Group | Methylcellulose capsules Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | mmol/L | baseline |
|
Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Bicarbonate Supplementation Group | 0.3 meq/kg/day NaHCO3 capsules Oral bicarbonate supplementation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| indigestion | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Snezana Petrovic, MD, PhD, FASN | Campbell University | (910) 893-1751 | spetrovic@campbell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2018 | May 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Dietary Supplement |
|
based on pill count |
| 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) | baseline |
| Carbon Dioxide Blood Test | Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L) | six months post baseline |
| 400 Meter Walk Time | baseline |
| 400 Meter Walk Time | three months post baseline |
| 400 Meter Walk Time | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | six months post baseline |
| Average Body Mass Index (BMI) | baseline |
| Average Body Mass Index (BMI) | three months post baseline |
| Average Body Mass Index (BMI) | 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. | 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. | 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. | six months post baseline |
| 3 months post randomization |
| Net Endogenous Acid Production (NEAP) | mEq/day by the kidney | Baseline |
| Withdrawn after Follow up 2 |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | mmol/L | six months post baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | Percent Adherence: Percentage of Pills Taken | based on pill count | Posted | Mean | Standard Deviation | percentage of pills | 6 months post baseline |
|
|
|
| Secondary | Carbon Dioxide Blood Test | Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L) | Posted | Mean | Standard Deviation | mEq/L | baseline |
|
|
|
| Secondary | Carbon Dioxide Blood Test | Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L) | Posted | Mean | Standard Deviation | mEq/L | six months post baseline |
|
|
|
| Secondary | 400 Meter Walk Time | Posted | Mean | Standard Deviation | minutes | baseline |
|
|
|
| Secondary | 400 Meter Walk Time | 1 bicarb Participant refused 400m walk at the 3-month visit. | Posted | Mean | Standard Deviation | minutes | three months post baseline |
|
|
|
| Secondary | 400 Meter Walk Time | 3 participants (2 bicarb and 1 placebo) refused 400m walk at the 6-month visit | Posted | Mean | Standard Deviation | minutes | six months post baseline |
|
|
|
| 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 | creatinine and MDRD equation | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | baseline |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | three months post baseline |
|
|
|
| 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 | creatinine and MDRD equation | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | six months post baseline |
|
|
|
| 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 | cystatin C and CKD Epi equation | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | baseline |
|
|
|
| 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 | cystatin C and CKD Epi equation | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | six months post baseline |
|
|
|
| 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. | No baseline dual energy x-ray absorptiometry (DXA) scans were completed for 3 bicarb and 1 placebo participants. | Posted | Mean | Standard Deviation | g/cm^3 | baseline |
|
|
|
| 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. | No 6-month DXA scans were completed for 1 bicarb and 3 placebo participants. | Posted | Mean | Standard Deviation | g/cm^3 | six months post baseline |
|
|
|
| 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. | No baseline DXA scans were completed for 3 bicarb and 1 placebo participants. | Posted | Mean | Standard Deviation | g/cm^3 | baseline |
|
|
|
| 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. | No 6-month DXA scans were completed for 1 bicarb and 3 placebo participants. | Posted | Mean | Standard Deviation | g/cm^3 | six months post baseline |
|
|
|
| Secondary | Average Body Mass Index (BMI) | 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). | Posted | Mean | Standard Deviation | kg/m^2 | baseline |
|
|
|
| Secondary | Average Body Mass Index (BMI) | 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). | Posted | Mean | Standard Deviation | kg/m^2 | three months post baseline |
|
|
|
| Secondary | Average Body Mass Index (BMI) | 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). | Posted | Mean | Standard Deviation | kg/m^2 | six months post baseline |
|
|
|
| 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. | baseline ACR is missing for 7 participants (3 bicarb and 4 placebo). | Posted | Mean | Standard Deviation | mg/g | baseline |
|
|
|
| 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. | 3-month ACR is missing for 10 participants (5 bicarb and 5 placebo). | Posted | Mean | Standard Deviation | mg/g | three months post baseline |
|
|
|
| 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. | 6-month ACR is missing for 5 participants (0 bicarb and 5 placebo). | Posted | Mean | Standard Deviation | mg/g | six months post baseline |
|
|
|
| Other Pre-specified | Net Endogenous Acid Production (NEAP) | (mEq/day) by the kidney | 6 month data missing for one subject in bicarbonate (bicarb) arm | Posted | Mean | Standard Deviation | mEq/day | 6 months post randomization |
|
|
|
| Other Pre-specified | Net Endogenous Acid Production (NEAP) | mEq/day by the kidney | Posted | Mean | Standard Deviation | mEq/day | 3 months post randomization |
|
|
|
| Other Pre-specified | Net Endogenous Acid Production (NEAP) | mEq/day by the kidney | Posted | Mean | Standard Deviation | mEq/day | Baseline |
|
|
|
| 0 |
| 41 |
| 1 |
| 41 |
| 8 |
| 41 |
| EG001 | Placebo Group | Methylcellulose capsules Placebo | 0 | 42 | 1 | 42 | 8 | 42 |
| Transient Ischemic Attack | Nervous system disorders | Systematic Assessment |
|
| Elevated Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| edema | Cardiac disorders | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Broken fifth toe right side | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |