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| Sponsor: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00357214 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Osteoporosis Sarcopenia |
Dietary Supplement: Potassium Bicarbonate Dietary Supplement: Sodium Bicarbonate Dietary Supplement: Potassium Chloride Dietary Supplement: placebo (microcrystalline cellulose) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Potassium Bicarbonate on Bone and Muscle |
| Estimated Enrollment: | 192 |
| Study Start Date: | September 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
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
|
|
Arm 2: Active Comparator
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
|
|
Arm 3: Active Comparator
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
|
|
Arm 4: Placebo Comparator
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
|
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:
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Bess Dawson-Hughes, MD | Tufts Medical Center |
More Information
| Responsible Party: | Tufts University ( Bess Dawson-Hughes, MD, Principal Investigator ) |
| Study ID Numbers: | R01 AR052322, 7743 |
| Study First Received: | July 26, 2006 |
| Last Updated: | January 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00357214 History of Changes |
| Health Authority: | United States: Federal Government |
|
bone turnover calcium excretion nitrogen excretion potassium bicarbonate |
muscle loss muscle atrophy bone loss |
|
Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis Bone Diseases, Metabolic Bone Diseases |
