N/A
N=171
Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults
Osteoporosis · Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT00357214 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Biochemical Markers of Bone Turnover — -6.25; -3.36; -0.14; 0.5 nmol/mmol
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potassium Bicarbonate (Dietary_supplement); Sodium Bicarbonate (Dietary_supplement); Potassium Chloride (Dietary_supplement); placebo (microcrystalline cellulose) (Dietary_supplement)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemical Markers of Bone Turnover |
-6.25; -3.36; -0.14; 0.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00357214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.