Status:
COMPLETED
Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults
Lead Sponsor:
Tufts University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Osteoporosis
Sarcopenia
Eligibility:
All Genders
50+ years
Phase:
NA
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 breakdow...
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 el...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00357214
Start Date
September 1 2006
End Date
April 1 2008
Last Update
February 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111