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

• Sponsor: Tufts University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00357214
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
• Enrollment: 171
• Location: 1
• Arms: 4
• Duration (Months): 19
• Patients Per Site Per Month: 9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Sarcopenia	Dietary Supplement: Potassium Bicarbonate; Dietary Supplement: Sodium Bicarbonate; Dietary Supplement: Potassium Chloride; Dietary Supplement: placebo (microcrystalline cellulose)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Potassium Bicarbonate on Bone and Muscle
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: potassium bicarbonate Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.	Dietary Supplement: Potassium Bicarbonate; 67.5 mmol/d given as three tablets after each meal, with a full glass of water
Active Comparator: Sodium bicarbonate Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.	Dietary Supplement: Sodium Bicarbonate; 67.5 mmol/d given as three tablets after each meal, with a full glass of water
Active Comparator: Potassium chloride Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.	Dietary Supplement: Potassium Chloride; 67.5 mmol/d given as three tablets after each meal, with a full glass of water
Placebo Comparator: microcrystalline cellulose Participants will receive placebo is microcrystalline cellulose. This compound has no other name.	Dietary Supplement: placebo (microcrystalline cellulose); Given as three tablets after each meal, with a full glass of water

Outcome Measures

Primary Outcome Measures

1. Biochemical Markers of Bone Turnover [3 month change in 24-hr urine values]

   Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts University
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• Principal Investigator: Bess Dawson-Hughes, MD, Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bess Dawson-Hughes, Senior Scientist, Tufts University
• ClinicalTrials.gov Identifier: NCT00357214
• Other Study ID Numbers: R01AR052322; R01AR052322
• First Posted: Jul 27, 2006
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Bess Dawson-Hughes, Senior Scientist, Tufts University: bone turnover; calcium excretion; nitrogen excretion; potassium bicarbonate; muscle loss; muscle atrophy; bone loss
• Additional relevant MeSH terms: Osteoporosis; Sarcopenia

Study Results

Participant Flow

Arm/Group Title	Potassium Bicarbonate	Sodium Bicarbonate	Potassium Chloride	Microcrystalline Cellulose
Arm/Group Description	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	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	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	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
Period Title: Overall Study
STARTED	43	43	42	43
COMPLETED	39	39	42	42
NOT COMPLETED	4	4	0	1

Baseline Characteristics

Arm/Group Title	Potassium Bicarbonate	Sodium Bicarbonate	Potassium Chloride	Microcrystalline Cellulose	Total
Arm/Group Description	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	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	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	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	Total of all reporting groups
Overall Participants	43	43	42	43	171
Age, Customized (years) [Mean (Standard Deviation) ]
participant age	62.2 (7.6)	62.6 (7.6)	63.4 (7.7)	63.3 (7.7)	62.9 (7.7)
Sex: Female, Male (Count of Participants)
Female	24 55.8%	24 55.8%	24 57.1%	25 58.1%	97 56.7%
Male	19 44.2%	19 44.2%	18 42.9%	18 41.9%	74 43.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	43 100%	43 100%	42 100%	43 100%	171 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Potassium Bicarbonate	Sodium Bicarbonate	Potassium Chloride	Microcrystalline Cellulose
Arm/Group Description	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	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	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	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
Measure Participants	39	39	42	42
Mean (Standard Error) [nmol/mmol]	-6.25 (1.75)	-3.36 (1.68)	-0.14 (1.71)	0.5 (1.61)

Adverse Events

Arm/Group Title	Potassium Bicarbonate		Sodium Bicarbonate		Potassium Chloride		Microcrystalline Cellulose
Arm/Group Description	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		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		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		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
All Cause Mortality
	Potassium Bicarbonate		Sodium Bicarbonate		Potassium Chloride		Microcrystalline Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Potassium Bicarbonate		Sodium Bicarbonate		Potassium Chloride		Microcrystalline Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/43 (0%)		0/42 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	Potassium Bicarbonate		Sodium Bicarbonate		Potassium Chloride		Microcrystalline Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/43 (2.3%)		3/43 (7%)		7/42 (16.7%)		1/43 (2.3%)
Gastrointestinal disorders
gastrointestinal symptoms	1/43 (2.3%)	1	3/43 (7%)	3	7/42 (16.7%)	7	1/43 (2.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.