OsteoporosisNCT00357214
Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults
A study testing Potassium Bicarbonate, Sodium Bicarbonate and Potassium Chloride in people with Osteoporosis and Sarcopenia, run by Tufts University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia
- What is being tested?
- Potassium Bicarbonate, Sodium Bicarbonate and Potassium Chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass idex less than 35
- Not currently on a weight gain or weight loss diet
- Willing to maintain usual level of physical activity
- Willing to refrain from taking own calcium supplements, antacids, or salt substitutes
Who cannot join
- Vegetarian
- Use of glucocorticoids for more than 10 days in the 3 months prior to study entry
- Use of estrogen, raloxifene, or calcitonin in the 6 months prior to study entry
- Use of bisphosphonate or teriparatide in the 2 years prior to study entry
- Current use of diuretics, nonsteroidal anti-inflammatory drugs (NSAIDS), beta-blockers, anabolic drugs (steroids or other), angiotensin converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs)
- Renal disease, including kidney stones in the 5 years prior to study entry or creatinine clearance less than 50 ml/min/1.73 m2 of body surface area
Show all 22Show fewer
- Hyperparathyroidism
- Untreated thyroid disease
- Significant immune disorder
- Current unstable heart disease
- Active malignancy or cancer therapy in the year prior to study entry
- 24-hour urine calcium levels greater than 300 mg/d after 1 week of being off calcium supplements
- Hypertension, congestive heart failure, arrythmias, or myocardial infarction in the 12 months prior to study entry
- On a salt-restricted diet
- Bone density total hip T score of less than -2.5
- Abnormal serum calcium
- Alkaline phosphatase levels greater than 10% above the upper end of the reference range
- Adrenal insufficiency, primary aldosteronism, or Bartter's syndrome
- Diabetes mellitus
- Alcohol use exceeding two drinks/day
- Peptic ulcers or esophageal stricture
- Screening serum 25(OH)D levels below 16 ng/ml
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: Effect of Potassium Bicarbonate on Bone and Muscle
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.
Read the detailed description
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:
- Group 1 will receive potassium bicarbonate supplements
- Group 2 will receive potassium chloride supplements
- Group 3 will receive sodium bicarbonate supplements
- Group 4 will receive placebo supplements
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.
- Conditions
- Osteoporosis, Sarcopenia
- Being tested
- Potassium Bicarbonate, Sodium Bicarbonate, Potassium Chloride, placebo (microcrystalline cellulose)
- Keywords
- bone turnover, calcium excretion, nitrogen excretion, potassium bicarbonate, muscle loss, muscle atrophy, bone loss
- Medical subject headings
- Osteoporosis, Sarcopenia, Muscular Atrophy, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium BicarbonateDietary supplement
67.5 mmol/d given as three tablets after each meal, with a full glass of water
Sodium BicarbonateDietary supplement
67.5 mmol/d given as three tablets after each meal, with a full glass of water
Potassium ChlorideDietary 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
| Study group | Role | What they receive |
|---|---|---|
| potassium bicarbonate | Active comparator | Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Receives: Dietary Supplement: Potassium Bicarbonate |
| Sodium bicarbonate | Active comparator | Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. Receives: Dietary Supplement: Sodium Bicarbonate |
| Potassium chloride | Active comparator | Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. Receives: Dietary Supplement: Potassium Chloride |
| microcrystalline cellulose | Placebo comparator | Participants will receive placebo is microcrystalline cellulose. This compound has no other name. Receives: Dietary Supplement: placebo (microcrystalline cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Markers of Bone Turnover
Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months
Measured: 3 month change in 24-hr urine values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Bess Dawson-Hughes, Tufts University
- Investigators
- Bess Dawson-Hughes, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357214
- Sponsor's protocol ID
- R01AR052322
- Other IDs
- R01AR052322
- Status last verified
- Feb 2020
- First submitted
- 26 Jul 2006
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18940881Dawson-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.
PubMed 19727904Harris 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.
PubMed 21046483
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Potassium Bicarbonate on Bone and Muscle
- ClinicalTrials.gov ID
- NCT00357214
- Acronym / sponsor ID
- R01AR052322
- Conditions
- Osteoporosis, Sarcopenia
- Keywords
- bone turnover, calcium excretion, nitrogen excretion, potassium bicarbonate, muscle loss, muscle atrophy, bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 27 Jul 2006 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Group 1 will receive potassium bicarbonate supplements
- Group 2 will receive potassium chloride supplements
- Group 3 will receive sodium bicarbonate supplements
- Group 4 will receive placebo supplements
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| potassium bicarbonate | Active comparator | Dietary Supplement: Potassium BicarbonateParticipants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. |
| Sodium bicarbonate | Active comparator | Dietary Supplement: Sodium BicarbonateParticipants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name. |
| Potassium chloride | Active comparator | Dietary Supplement: Potassium ChlorideParticipants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name. |
| microcrystalline cellulose | Placebo comparator | Dietary Supplement: placebo (microcrystalline cellulose)Participants will receive placebo is microcrystalline cellulose. This compound has no other name. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass idex less than 35
- Not currently on a weight gain or weight loss diet
- Willing to maintain usual level of physical activity
- Willing to refrain from taking own calcium supplements, antacids, or salt substitutes
Key exclusion criteria (22 listed)
- Vegetarian
- Use of glucocorticoids for more than 10 days in the 3 months prior to study entry
- Use of estrogen, raloxifene, or calcitonin in the 6 months prior to study entry
- Use of bisphosphonate or teriparatide in the 2 years prior to study entry
- Current use of diuretics, nonsteroidal anti-inflammatory drugs (NSAIDS), beta-blockers, anabolic drugs (steroids or other), angiotensin converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium Bicarbonate67.5 mmol/d given as three tablets after each meal, with a full glass of water | Dietary supplement | potassium bicarbonate |
| Sodium Bicarbonate67.5 mmol/d given as three tablets after each meal, with a full glass of water | Dietary supplement | Sodium bicarbonate |
| Potassium Chloride67.5 mmol/d given as three tablets after each meal, with a full glass of water | Dietary supplement | Potassium chloride |
| placebo (microcrystalline cellulose)Given as three tablets after each meal, with a full glass of water | Dietary supplement | microcrystalline cellulose |
Primary outcome
Biochemical Markers of Bone Turnover
Time frame: 3 month change in 24-hr urine values
Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18940881Dawson-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.
- Results publication: PubMed 19727904Dawson-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.
- Derived from this study: PubMed 21046483Harris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bess Dawson-Hughes, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium Bicarbonate, Sodium Bicarbonate and Potassium Chloride in people with Osteoporosis and Sarcopenia, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Markers of Bone Turnover (time frame: 3 month change in 24-hr urine values). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00357214, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.