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

NCT ID: NCT00357214

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-04-30

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.

Conditions

Osteoporosis; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

potassium bicarbonate

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

Group Type: ACTIVE_COMPARATOR

Potassium Bicarbonate

Intervention Type: DIETARY_SUPPLEMENT

67.5 mmol/d given as three tablets after each meal, with a full glass of water

Sodium bicarbonate

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

Group Type: ACTIVE_COMPARATOR

Sodium Bicarbonate

Intervention Type: DIETARY_SUPPLEMENT

67.5 mmol/d given as three tablets after each meal, with a full glass of water

Potassium chloride

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

Group Type: ACTIVE_COMPARATOR

Potassium Chloride

Intervention Type: DIETARY_SUPPLEMENT

67.5 mmol/d given as three tablets after each meal, with a full glass of water

microcrystalline cellulose

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

Group Type: PLACEBO_COMPARATOR

placebo (microcrystalline cellulose)

Intervention Type: DIETARY_SUPPLEMENT

Given as three tablets after each meal, with a full glass of water

Interventions

Potassium Bicarbonate

67.5 mmol/d given as three tablets after each meal, with a full glass of water

Intervention Type: DIETARY_SUPPLEMENT

Sodium Bicarbonate

67.5 mmol/d given as three tablets after each meal, with a full glass of water

Intervention Type: DIETARY_SUPPLEMENT

Potassium Chloride

67.5 mmol/d given as three tablets after each meal, with a full glass of water

Intervention Type: DIETARY_SUPPLEMENT

placebo (microcrystalline cellulose)

Given as three tablets after each meal, with a full glass of water

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Bess Dawson-Hughes

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bess Dawson-Hughes, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18940881 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19727904 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21046483 (View on PubMed)

Other Identifiers

R01AR052322

Identifier Type: NIH

Identifier Source: secondary_id

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R01AR052322

Identifier Type: NIH

Identifier Source: org_study_id

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