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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR052322 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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There is increasing evidence that the acid-base balance of diet plays an important role in the health of bones and muscles. An excess of acid in the body can result in calcium loss and muscle breakdown. Potassium bicarbonate, a base supplement, can neutralize acid within the body. The purpose of this study is to determine the effectiveness of potassium and bicarbonate, alone and combined, at reducing bone loss and preventing muscle wasting in older adults.
The typical American diet of dairy products, grains, and meats results in excess acid build-up in the body. The kidney is often unable to remove this excess acid quickly enough, resulting in mildly elevated blood acidity. In an attempt to neutralize the acidity, the body releases calcium from its bones. Over time, however, this calcium loss can lead to decreased bone density and possibly osteoporosis. Excess acid in the body also stimulates the breakdown of muscle. The combination of osteoporosis and reduced muscle strength sets the stage for falls, fractures, and ultimately functional decline. At least 30% of older adults fall once a year and, of those falls, 5% result in fractures. Preserving muscle mass and strength is an effective way to lower the risk of falling and to maintain independence among older people. Potassium bicarbonate is a base supplement that can neutralize acid. The purpose of this study is to determine the effectiveness of potassium and bicarbonate, alone and combined, at reducing bone loss and preventing muscle wasting in older adults.
This study will last 3 months. Participants will be randomly assigned to one of four treatment groups:
All participants will take three pills of their assigned supplement after each meal; this will occur on a daily basis throughout the study. Participants will also take a multivitamin and a 600-mg calcium tablet daily. Participants will not be required to alter their usual diet in any way, but they will be requested to not take their usual calcium and vitamin D supplements during the study. Study visits will occur on Days 1, 21, 49, and 84. Days 1 and 84 study visits will include a review of medical history and physical activity, blood collection, and evaluation of weight, blood pressure, calcium absorption, and muscle function. Collection of both a 24-hour urine sample and a calendar depicting compliance with the supplement schedule will also occur at these two visits. The other study visits, on Days 21 and 49, may include blood collection, calendar compliance checking, and weight and blood pressure measurements. Supplements will be handed out on Days 1, 21, and 49.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| potassium bicarbonate | Active Comparator | Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. |
|
| Sodium bicarbonate | Active Comparator | Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. |
|
| Potassium chloride | Active Comparator | Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. |
|
| microcrystalline cellulose | Placebo Comparator | Participants will receive placebo is microcrystalline cellulose. This compound has no other name. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Bicarbonate | Dietary Supplement | 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Markers of Bone Turnover | Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months | 3 month change in 24-hr urine values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bess Dawson-Hughes, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18940881 | Result | Dawson-Hughes B, Harris SS, Palermo NJ, Castaneda-Sceppa C, Rasmussen HM, Dallal GE. Treatment with potassium bicarbonate lowers calcium excretion and bone resorption in older men and women. J Clin Endocrinol Metab. 2009 Jan;94(1):96-102. doi: 10.1210/jc.2008-1662. Epub 2008 Oct 21. | |
| 19727904 | Result | Dawson-Hughes B, Castaneda-Sceppa C, Harris SS, Palermo NJ, Cloutier G, Ceglia L, Dallal GE. Impact of supplementation with bicarbonate on lower-extremity muscle performance in older men and women. Osteoporos Int. 2010 Jul;21(7):1171-9. doi: 10.1007/s00198-009-1049-0. Epub 2009 Sep 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Potassium Bicarbonate | Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
| FG001 | Sodium Bicarbonate | Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
| FG002 | Potassium Chloride | Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
| FG003 | Microcrystalline Cellulose | Participants will receive placebo is microcrystalline cellulose. This compound has no other name. placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Potassium Bicarbonate | Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
| BG001 | Sodium Bicarbonate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Biochemical Markers of Bone Turnover | Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months | Posted | Mean | Standard Error | nmol/mmol | 3 month change in 24-hr urine values |
|
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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 | Potassium Bicarbonate | Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Potassium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal symptoms | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bess Dawson-Hughes | Tufts University | 617 556 3066 | 6175100519 | bess.dawson-hughes@tufts.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C026329 | potassium bicarbonate |
| D017693 | Sodium Bicarbonate |
| D011189 | Potassium Chloride |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Sodium Bicarbonate | Dietary Supplement | 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
|
| Potassium Chloride | Dietary Supplement | 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
|
| placebo (microcrystalline cellulose) | Dietary Supplement | Given as three tablets after each meal, with a full glass of water |
|
| 21046483 | Derived | Harris SS, Dawson-Hughes B. No effect of bicarbonate treatment on insulin sensitivity and glucose control in non-diabetic older adults. Endocrine. 2010 Oct;38(2):221-6. doi: 10.1007/s12020-010-9377-6. Epub 2010 Jul 17. |
Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
| BG002 | Potassium Chloride | Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
| BG003 | Microcrystalline Cellulose | Participants will receive placebo is microcrystalline cellulose. This compound has no other name. placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Potassium Chloride | Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water |
| OG003 | Microcrystalline Cellulose | Participants will receive placebo is microcrystalline cellulose. This compound has no other name. placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water |
|
|
| 0 |
| 43 |
| 1 |
| 43 |
| EG001 | Sodium Bicarbonate | Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Sodium Bicarbonate: 67.5 mmol/d given as three tablets after each meal, with a full glass of water | 0 | 43 | 3 | 43 |
| EG002 | Potassium Chloride | Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Potassium Chloride: 67.5 mmol/d given as three tablets after each meal, with a full glass of water | 0 | 42 | 7 | 42 |
| EG003 | Microcrystalline Cellulose | Participants will receive placebo is microcrystalline cellulose. This compound has no other name. placebo (microcrystalline cellulose): Given as three tablets after each meal, with a full glass of water | 0 | 43 | 1 | 43 |
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| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017680 | Potassium Compounds |
| Male |
|