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Dietary Acid Load, Kidney Function and Disability in Elderly (BICARB)

Primary Purpose

Chronic Kidney Disease, Disability

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral bicarbonate supplementation
Placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Geriatric, bicarbonate

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 65 +years of age
  • SPPB (short physical performance battery) score>3
  • 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 (SBP>160, DBP>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
  • 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 HCO3>30meq/L; serum K+ out of normal range

Sites / Locations

  • Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral bicarbonate supplementation group

Placebo group

Arm Description

0.3 meq/kg/day NaHCO3 capsules

Methylcellulose capsules

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
Percent Adherence: Percentage of Pills Taken
based on pill count
Carbon Dioxide Blood Test
Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)
Carbon Dioxide Blood Test
Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)
400 Meter Walk Time
400 Meter Walk Time
400 Meter Walk Time
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
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
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
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
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
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.
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.
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.
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.
Average Body Mass Index (BMI)
Average Body Mass Index (BMI)
Average Body Mass Index (BMI)
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.
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.
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.

Full Information

First Posted
February 22, 2016
Last Updated
September 21, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02691663
Brief Title
Dietary Acid Load, Kidney Function and Disability in Elderly
Acronym
BICARB
Official Title
Dietary Acid Load, Kidney Function and Disability in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Disability
Keywords
Geriatric, bicarbonate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral bicarbonate supplementation group
Arm Type
Active Comparator
Arm Description
0.3 meq/kg/day NaHCO3 capsules
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Methylcellulose capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral bicarbonate supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Blood Bicarbonate
Description
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
Title
Blood Bicarbonate
Description
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 Outcome Measure Information:
Title
Percentage of Screened Participants Randomized
Description
The number of participants randomized divided by the number of participants screened. Count of participants reflects the number of participants randomized.
Time Frame
baseline
Title
Percent Adherence: Percentage of Pills Taken
Description
based on pill count
Time Frame
6 months post baseline
Title
Carbon Dioxide Blood Test
Description
Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)
Time Frame
baseline
Title
Carbon Dioxide Blood Test
Description
Blood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)
Time Frame
six months post baseline
Title
400 Meter Walk Time
Time Frame
baseline
Title
400 Meter Walk Time
Time Frame
three months post baseline
Title
400 Meter Walk Time
Time Frame
six months post baseline
Title
Estimated Glomerular Filtration Rate (eGFR)
Description
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
Title
Estimated Glomerular Filtration Rate (eGFR)
Description
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
Title
Estimated Glomerular Filtration Rate (eGFR)
Description
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
Title
Measurement of Kidney Function (eGFR) at Baseline.
Description
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
Title
Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline
Description
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
Title
Hip Bone Mineral Density
Description
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Time Frame
baseline
Title
Hip Bone Mineral Density
Description
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
Title
Femoral Neck Bone Mineral Density
Description
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Time Frame
baseline
Title
Femoral Neck Bone Mineral Density
Description
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
Title
Average Body Mass Index (BMI)
Time Frame
baseline
Title
Average Body Mass Index (BMI)
Time Frame
three months post baseline
Title
Average Body Mass Index (BMI)
Time Frame
six months post baseline
Title
Urinary Albumin to Creatinine Ratio (ACR)
Description
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
Title
Urinary Albumin to Creatinine Ratio (ACR)
Description
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
Title
Urinary Albumin to Creatinine Ratio (ACR)
Description
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 Pre-specified Outcome Measures:
Title
Net Endogenous Acid Production (NEAP)
Description
(mEq/day) by the kidney
Time Frame
6 months post randomization
Title
Net Endogenous Acid Production (NEAP)
Description
mEq/day by the kidney
Time Frame
3 months post randomization
Title
Net Endogenous Acid Production (NEAP)
Description
mEq/day by the kidney
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Snezana Petrovic, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dietary Acid Load, Kidney Function and Disability in Elderly

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