N/A
N=83
Dietary Acid Load, Kidney Function and Disability in Elderly
Chronic Kidney Disease · Disability
Bottom Line
View on ClinicalTrials.gov: NCT02691663 ↗Enrolled (actual)
83
Serious AEs
2.4%
Results posted
Sep 2023
Primary outcome: Primary: Blood Bicarbonate — 22.8; 23.2 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oral bicarbonate supplementation (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Bicarbonate |
23.8; 23.3 | — |
| PRIMARY Blood Bicarbonate |
23.8; 23.3 | — |
| SECONDARY Percentage of Screened Participants Randomized |
83 | — |
| SECONDARY Percent Adherence: Percentage of Pills Taken |
90.5; 85.2 | — |
| SECONDARY Carbon Dioxide Blood Test |
36.9; 37.0 | — |
| SECONDARY Carbon Dioxide Blood Test |
36.9; 37.0 | — |
| SECONDARY 400 Meter Walk Time |
6.1; 6.3 | — |
| SECONDARY 400 Meter Walk Time |
6.1; 6.3 | — |
| SECONDARY 400 Meter Walk Time |
6.1; 6.3 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) |
64.7; 64.7 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) |
64.7; 64.7 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) |
64.7; 64.7 | — |
| SECONDARY Measurement of Kidney Function (eGFR) at Baseline. |
81.3; 81.3 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline |
80.1; 81.0 | — |
| SECONDARY Hip Bone Mineral Density |
.93; .91 | — |
| SECONDARY Hip Bone Mineral Density |
.93; .91 | — |
| SECONDARY Femoral Neck Bone Mineral Density |
.74; .72 | — |
| SECONDARY Femoral Neck Bone Mineral Density |
.74; .72 | — |
| SECONDARY Average Body Mass Index (BMI) |
26.3; 28.1 | — |
| SECONDARY Average Body Mass Index (BMI) |
26.3; 28.1 | — |
| SECONDARY Average Body Mass Index (BMI) |
26.3; 28.1 | — |
| SECONDARY Urinary Albumin to Creatinine Ratio (ACR) |
45.1; 80.4 | — |
| SECONDARY Urinary Albumin to Creatinine Ratio (ACR) |
45.1; 80.4 | — |
| SECONDARY Urinary Albumin to Creatinine Ratio (ACR) |
45.1; 80.4 | — |
Summary
The purpose of this research study is to determine the effect of a bicarbonate supplement on kidney function and physical function.
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 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
Data sourced from ClinicalTrials.gov (NCT02691663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.