Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.
This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Bicarbonate | Active Comparator | Sequential design. Participants will be getting different doses of sodium bicarbonate during the study. |
|
| Placebos | Placebo Comparator | Sequential design. Participants will be getting either placebo of different doses during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Bicarbonate Levels | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Strength as Measured by sit-to Stand Test | 10 repetition sit-to-stand test | 8 weeks |
| Systolic Blood Pressure | 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Hostetter, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine/ Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27495287 | Background | Chen W, Melamed ML, Hostetter TH, Bauer C, Raff AC, Almudevar AL, Lalonde A, Messing S, Abramowitz MK. Effect of oral sodium bicarbonate on fibroblast growth factor-23 in patients with chronic kidney disease: a pilot study. BMC Nephrol. 2016 Aug 5;17(1):114. doi: 10.1186/s12882-016-0331-6. | |
| 23393105 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will receive both active treatment and placebo. Therefore the 20 patients who started placebo also started active treatment. There are only 20 participants total in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Sequential design. Participants all began with taking placebo for 2 weeks and started sodium bicarbonate using escalating doses of sodium bicarbonate with a dose increase every 2 weeks (0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants went through sequential dosing of placebo, then sodium bicarbonate escalating doses. |
| 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 | Serum Bicarbonate Levels | Posted | Mean | Standard Deviation | mEq/L | 8 weeks |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Bicarbonate | Crossover design. Participants will be getting different doses of sodium bicarbonate during the study. Sodium bicarbonate: Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michal Melamed | Albert Einstein College of Medicine | 718-430-2496 | michal.melamed@einsteinmed.org |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebos | Drug | Placebo at 3 different doses to match Sodium bicarbonate dosing |
|
|
| Abramowitz MK, Melamed ML, Bauer C, Raff AC, Hostetter TH. Effects of oral sodium bicarbonate in patients with CKD. Clin J Am Soc Nephrol. 2013 May;8(5):714-20. doi: 10.2215/CJN.08340812. Epub 2013 Feb 7. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Serum Bicarbonate Levels | Mean | Standard Deviation | mEq/L |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Muscle Strength as Measured by sit-to Stand Test | 10 repetition sit-to-stand test | Posted | Mean | Standard Deviation | Seconds | 8 weeks |
|
|
|
| Secondary | Systolic Blood Pressure | Posted | Median | Inter-Quartile Range | mmHg | 8 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Placebos | Crossover design. Participants will be getting either placebo of different doses during the study. Placebos: Placebo at 3 different doses to match Sodium bicarbonate dosing | 0 | 20 | 0 | 20 | 1 | 20 |
Not provided
Not provided
Not provided
| 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 |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |