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Potassium Citrate to Prevent Age Related Bone Loss

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potassium citrate
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Calcium balance

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Good general health Exclusion Criteria: Abnormal kidney, liver, or bone function Currently taking medications that might affect potassium or bone

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Participants will receive 90 meq of potassium citrate.

Participants will receive 60 meq of potassium citrate.

Participants will receive placebo.

Outcomes

Primary Outcome Measures

calcium balance

Secondary Outcome Measures

Full Information

First Posted
January 23, 2006
Last Updated
August 8, 2014
Sponsor
University of California, San Francisco
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00282126
Brief Title
Potassium Citrate to Prevent Age Related Bone Loss
Official Title
Potassium Citrate to Prevent Age Related Bone Loss: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Calcium balance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive 90 meq of potassium citrate.
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive 60 meq of potassium citrate.
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Potassium citrate
Intervention Description
kcitrate
Primary Outcome Measure Information:
Title
calcium balance
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Good general health Exclusion Criteria: Abnormal kidney, liver, or bone function Currently taking medications that might affect potassium or bone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Sellmeyer, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Potassium Citrate to Prevent Age Related Bone Loss

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