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Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults

Primary Purpose

Osteoporosis, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potassium Bicarbonate
Sodium Bicarbonate
Potassium Chloride
placebo (microcrystalline cellulose)
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring bone turnover, calcium excretion, nitrogen excretion, potassium bicarbonate, muscle loss, muscle atrophy, bone loss

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

potassium bicarbonate

Sodium bicarbonate

Potassium chloride

microcrystalline cellulose

Arm Description

Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.

Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.

Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.

Participants will receive placebo is microcrystalline cellulose. This compound has no other name.

Outcomes

Primary Outcome Measures

Biochemical Markers of Bone Turnover
Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months

Secondary Outcome Measures

Full Information

First Posted
July 26, 2006
Last Updated
February 4, 2020
Sponsor
Tufts University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00357214
Brief Title
Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults
Official Title
Effect of Potassium Bicarbonate on Bone and Muscle
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Sarcopenia
Keywords
bone turnover, calcium excretion, nitrogen excretion, potassium bicarbonate, muscle loss, muscle atrophy, bone loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
potassium bicarbonate
Arm Type
Active Comparator
Arm Description
Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.
Arm Title
Sodium bicarbonate
Arm Type
Active Comparator
Arm Description
Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.
Arm Title
Potassium chloride
Arm Type
Active Comparator
Arm Description
Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.
Arm Title
microcrystalline cellulose
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo is microcrystalline cellulose. This compound has no other name.
Intervention Type
Dietary Supplement
Intervention Name(s)
Potassium Bicarbonate
Intervention Description
67.5 mmol/d given as three tablets after each meal, with a full glass of water
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
67.5 mmol/d given as three tablets after each meal, with a full glass of water
Intervention Type
Dietary Supplement
Intervention Name(s)
Potassium Chloride
Intervention Description
67.5 mmol/d given as three tablets after each meal, with a full glass of water
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo (microcrystalline cellulose)
Intervention Description
Given as three tablets after each meal, with a full glass of water
Primary Outcome Measure Information:
Title
Biochemical Markers of Bone Turnover
Description
Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months
Time Frame
3 month change in 24-hr urine values

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bess Dawson-Hughes, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18940881
Citation
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.
Results Reference
result
PubMed Identifier
19727904
Citation
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.
Results Reference
result
PubMed Identifier
21046483
Citation
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.
Results Reference
derived

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Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults

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