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Potassium Citrate to Prevent Age Related Bone Loss

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00282126
First received: January 23, 2006
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

Osteoporosis, a disease in which the bones become weak and are more likely to break, is a major health problem in the United States. Too much acid in the body appears to be linked to loss of calcium via urine, bone loss, and muscle breakdown. The purpose of this study is to determine the effect of various doses of potassium citrate, a supplement that can neutralize acid, on bone density and muscle mass in older, healthy adults.


Condition Intervention
Osteoporosis
 Drug: Potassium citrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Potassium Citrate to Prevent Age Related Bone Loss: Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • calcium balance [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive 90 meq of potassium citrate.
 Drug: Potassium citrate
kcitrate
Experimental: 2
Participants will receive 60 meq of potassium citrate.
 Drug: Potassium citrate
kcitrate
Placebo Comparator: 3
Participants will receive placebo.
 Drug: Potassium citrate
kcitrate

Detailed Description:

Over 10 million adults in the United States have osteoporosis, and another 18 million have low bone mass, a risk factor for developing this disease. Each year, approximately 1.5 million fractures are associated with osteoporosis. Adequate intake of calcium and vitamin D is the current nutritional approach to preventing age-related bone loss. However, even with sufficient levels of these nutrients, bone loss can still occur. Too much acid in the body, caused by diet, aging, and protein metabolism, appears to be linked to loss of calcium via urine, bone loss, and muscle breakdown. Potassium citrate can neutralize acids. The purpose of this study is to determine the effect of various doses of potassium citrate on bone density and muscle mass in older, healthy adults.

This study will last 6 months. Baseline measurements will take place from Weeks 1 through 4. During this time, participants will first receive a placebo over a 2-week period. Participants will then undergo a calcium balance study, involving consumption of certain study foods for 12 days and an overnight stay at the research unit for a calcium absorption test. The calcium balance study will be followed by blood collection. At Week 5, participants will be randomly assigned to receive either potassium citrate or placebo daily. For the first 9 weeks of treatment, there will be weekly blood collection and periodic urine collection for all participants. At Month 6, blood and urine will again be collected, and participants will complete questionnaires on diet and physical activity, and a second calcium balance study.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health

Exclusion Criteria:

  • Abnormal kidney, liver, or bone function
  • Currently taking medications that might affect potassium or bone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282126

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
University of California, San Francisco
Johns Hopkins University
Investigators
Principal Investigator: Deborah Sellmeyer, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00282126     History of Changes
Other Study ID Numbers: N01 AR052275, 27653
Study First Received: January 23, 2006
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Calcium balance

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Citric Acid
Potassium Citrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 13, 2013