NCT00282126

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

5 years

First QC Date

January 23, 2006

Last Update Submit

August 8, 2014

Conditions

Osteoporosis

Keywords

Calcium balance

Outcome Measures

Primary Outcomes (1)

  • calcium balance

    six months

Study Arms (3)

1

EXPERIMENTAL

Participants will receive 90 meq of potassium citrate.

Dietary Supplement: Potassium citrate

2

EXPERIMENTAL

Participants will receive 60 meq of potassium citrate.

Dietary Supplement: Potassium citrate

3

PLACEBO COMPARATOR

Participants will receive placebo.

Dietary Supplement: Potassium citrate

Interventions

Potassium citrateDIETARY_SUPPLEMENT

kcitrate

123

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good general health

You may not qualify if:

  • Abnormal kidney, liver, or bone function
  • Currently taking medications that might affect potassium or bone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Potassium Citrate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Citric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Deborah Sellmeyer, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 25, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2011

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

US(1)