Osteoporosis Clinical Trial
Official title:
Effect of Potassium Bicarbonate on Bone and Muscle
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.
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.
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