Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults
1 other identifier
interventional
171
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 27, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
February 5, 2020
CompletedFebruary 17, 2020
February 1, 2020
1.6 years
July 26, 2006
September 18, 2019
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
potassium bicarbonate
ACTIVE COMPARATORParticipants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.
Sodium bicarbonate
ACTIVE COMPARATORParticipants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.
Potassium chloride
ACTIVE COMPARATORParticipants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.
microcrystalline cellulose
PLACEBO COMPARATORParticipants will receive placebo is microcrystalline cellulose. This compound has no other name.
Interventions
67.5 mmol/d given as three tablets after each meal, with a full glass of water
67.5 mmol/d given as three tablets after each meal, with a full glass of water
67.5 mmol/d given as three tablets after each meal, with a full glass of water
Given as three tablets after each meal, with a full glass of water
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Hyperparathyroidism
- Untreated thyroid disease
- Significant immune disorder
- Current unstable heart disease
- Active malignancy or cancer therapy in the year prior to study entry
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (3)
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.
PMID: 18940881RESULTDawson-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.
PMID: 19727904RESULTHarris 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.
PMID: 21046483DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bess Dawson-Hughes
- Organization
- Tufts University
Study Officials
- PRINCIPAL INVESTIGATOR
Bess Dawson-Hughes, MD
Tufts Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 27, 2006
Study Start
September 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
February 17, 2020
Results First Posted
February 5, 2020
Record last verified: 2020-02