Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282126
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2006-01-23
Brief Title:
Potassium Citrate to Prevent Age Related Bone Loss
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Potassium Citrate to Prevent Age Related Bone Loss Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 15 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 27653 | None | None | None |