Potassium Citrate to Prevent Age Related Bone Loss

Osteoporosis Clinical Trial

Official title:

Potassium Citrate to Prevent Age Related Bone Loss: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282126
• Other study ID #: N01 AR052275
• Secondary ID: 27653
• Status: Completed
• Phase: N/A
• First received: January 23, 2006
• Last updated: August 8, 2014
• Start date: January 2006

Study information

• Verified date: August 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

Inclusion Criteria:

• Good general health

Exclusion Criteria:

• Abnormal kidney, liver, or bone function

• Currently taking medications that might affect potassium or bone

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• Potassium citrate
kcitrate

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calcium balance		six months	No