Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00357214
First received: July 26, 2006
Last updated: August 8, 2011
Last verified: August 2011

July 26, 2006
August 8, 2011
September 2006
April 2008   (final data collection date for primary outcome measure)
  • Biochemical markers of bone turnover [ Time Frame: 9/06 - 5/08 ] [ Designated as safety issue: No ]
  • Urinary calcium excretion [ Time Frame: 9/06 - 5/08 ] [ Designated as safety issue: Yes ]
  • Urinary nitrogen excretion [ Time Frame: 9/06 - 5/08 ] [ Designated as safety issue: No ]
  • biochemical markers of bone turnover
  • urinary clcium excretion
  • urinary nitrogen excretion
Complete list of historical versions of study NCT00357214 on ClinicalTrials.gov Archive Site
  • Serum parathyroid hormone [ Time Frame: 9/06 - 5/08 ] [ Designated as safety issue: No ]
  • Muscle strength [ Time Frame: 9/06 - 5/08 ] [ Designated as safety issue: No ]
  • serum parathyroid hormone
  • muscle strength
Not Provided
Not Provided
 
Effect of Potassium Bicarbonate Supplementation on Bone and Muscle in Older Adults
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Osteoporosis
  • Sarcopenia
  • Dietary Supplement: Potassium Bicarbonate
    67.5 mmol/d given as three tablets after each meal, with a full glass of water
  • Dietary Supplement: Sodium Bicarbonate
    67.5 mmol/d given as three tablets after each meal, with a full glass of water
  • Dietary Supplement: Potassium Chloride
    67.5 mmol/d given as three tablets after each meal, with a full glass of water
  • Dietary Supplement: placebo (microcrystalline cellulose)
    Given as three tablets after each meal, with a full glass of water
  • Active Comparator: 1
    Participants will receive potassium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.
    Intervention: Dietary Supplement: Potassium Bicarbonate
  • Active Comparator: Arm 2
    Participants will receive sodium bicarbonate in dosage of 67.5 mmol/d. This compound has no other name.
    Intervention: Dietary Supplement: Sodium Bicarbonate
  • Active Comparator: Arm 3
    Participants will receive potassium chloride in dosage of 67.5 mmol/d. This compound has no other name.
    Intervention: Dietary Supplement: Potassium Chloride
  • Placebo Comparator: Arm 4
    Participants will receive placebo is microcrystalline cellulose. This compound has no other name.
    Intervention: Dietary Supplement: placebo (microcrystalline cellulose)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00357214
R01 AR052322, R01AR052322, 7743
No
Bess Dawson-Hughes, MD, Principal Investigator, Tufts University
Tufts University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Bess Dawson-Hughes, MD Tufts Medical Center
Tufts University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP