Value of Liquid Potassium Magnesium Citrate in Controllin... | NCT01682837 | Trialant
NCT01682837
Sponsor
University of Texas Southwestern Medical Center
Status
Completed
Last Update Posted
Apr 28, 2017Actual
Enrollment
35Actual
Phase
Phase 2
Conditions
Hypertension
Interventions
Potassium chloride powder
Potassium citrate powder
Potassium magnesium citrate powder
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01682837
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
LiqKMgCit-1208-01
Secondary IDs
Not provided
Brief Title
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Official Title
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Acronym
Not provided
Organization
University of Texas Southwestern Medical CenterOTHER
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2012
Primary Completion Date
Mar 2015Actual
Completion Date
Mar 2015Actual
First Submitted Date
Sep 4, 2012
First Submission Date that Met QC Criteria
Sep 7, 2012
First Posted Date
Sep 11, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 22, 2016
Results First Submitted that Met QC Criteria
Mar 17, 2017
Results First Posted Date
Apr 28, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 17, 2017
Last Update Posted Date
Apr 28, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University of Texas Southwestern Medical CenterOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.
Detailed Description
In this protocol, the investigators want to explore whether KMgCit taken during a customary dietary setting, might serve as a "surrogate" for the Dietary Approaches to Stop Hypertension (DASH) diet to lower blood pressure. This study has obvious biomedical importance. Lifestyle modifications are often recommended for pre- or Stage I hypertension. The DASH diet is such a modification that has been shown to be effective. However, this diet is costly and difficult to adhere to long-term. If KMgCit were shown to be effective in lowering blood pressure, it would provide a safe and convenient alternative to the DASH diet.
Conditions Module
Conditions
Hypertension
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
35Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
KMgCit, KCit, KCl, Placebo
Experimental
Participants who received study drug in the order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KMgCit, KCit, Placebo, KCl
Experimental
Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KMgCit, KCl, KCit, Placebo
Experimental
Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KMgCit, KCl, Placebo, KCit
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Potassium chloride powder
Drug
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks
KCit, KCl, KMgCit, Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
24-hour Average Systolic Blood Pressure
This is the average systolic blood pressure over a 24 hour period.
4 weeks
24-hour Average Diastolic Blood Pressure
The average diastolic blood pressure over a 24 hour period.
4 weeks
Secondary Outcomes
Measure
Description
Time Frame
Office Systolic Blood Pressure
4 weeks
Office Diastolic Blood Pressure
4 weeks
Serum C-terminal Telopeptide (CTX)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men or women > 21 years of age
Any Race/Ethnicity
Pre- or Stage I hypertension (BP >= 120/80 and <= 159/99)
Exclusion Criteria:
Diabetes mellitus
Renal impairment (serum creatinine > 1.4 mg/dL)
Any heart diseases such as congestive heart failure or sustained arrhythmia
Chronic NSAID use
Treatment with diuretics
Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week
Esophageal-gastric ulcer
Chronic diarrhea
Hyperkalemia (serum > 4.6 meq/L for patients on angiotension-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), serum K > 5.0 meq/L for patient not on ACE inhibitors or ARBs)
Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase (ALT) above upper limit of normal range)
Subjects who require any potassium supplement on a regular basis from any reasons
Pregnancy
History of major depression, bipolar disorder, or schizophrenia
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
21 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Wanpen Vongpatanasin, MD
University of Texas Southwestern Medical Center
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Hypertension Clinic - UT Southwestern Medical Center at Dallas
Vongpatanasin W, Peri-Okonny P, Velasco A, Arbique D, Wang Z, Ravikumar P, Adams-Huet B, Moe OW, Pak CYC. Effects of Potassium Magnesium Citrate Supplementation on 24-Hour Ambulatory Blood Pressure and Oxidative Stress Marker in Prehypertensive and Hypertensive Subjects. Am J Cardiol. 2016 Sep 15;118(6):849-853. doi: 10.1016/j.amjcard.2016.06.041. Epub 2016 Jun 28.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
All Study Participants
Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.
Periods
Title
Milestones
Reasons Not Completed
Baseline
Type
Comment
Milestone Data
STARTED
FG00035 subjects
COMPLETED
FG00030 subjects
NOT COMPLETED
FG0005 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0005 subjects
First Intervention (4 Weeks)
Type
Comment
Milestone Data
STARTED
FG00030 subjects
Received KMgCit
FG0008 subjects
Received KCit
FG000
Second Intervention (4 Weeks)
Type
Comment
Milestone Data
STARTED
FG00030 subjects
Received KMgCit
FG0007 subjects
Received KCit
FG000
Third Intervention (4 Weeks)
Type
Comment
Milestone Data
STARTED
FG00030 subjects
Received KMgCit
FG0009 subjects
Received KCit
FG000
Fourth Intervention (4 Weeks)
Type
Comment
Milestone Data
STARTED
FG00030 subjects
Received KMgCit
FG0006 subjects
Received KCit
FG000
Baseline Characteristics Module
Baseline Analysis Population Description
Thirty (30) subjects participated in the trial. Each subject completed all four phases of the trial.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Study Participants
Participants received the following study drug in random order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
24-hour Average Systolic Blood Pressure
This is the average systolic blood pressure over a 24 hour period.
All participants who completed the study completed all 4 phases.
Posted
Mean
Standard Deviation
mmHg
4 weeks
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Adverse Events Module
Frequency Threshold
0
Time Frame
Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Description
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KMgCit, Placebo, KCit, KCl
Experimental
Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KMgCit, Placebo, KCl, KCit
Experimental
Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCit, KMgCit, KCl, Placebo
Experimental
Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCit, KMgCit, Placebo, KCl
Experimental
Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCit, KCl, KMgCit, Placebo
Experimental
Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCit, KCl, Placebo, KMgCit
Experimental
Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCit, Placebo, KMgCit, KCl
Experimental
Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCit, Placebo, KCl, KMgCit
Experimental
Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCl, KMgCit, KCit, Placebo
Experimental
Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCl, KMgCit, Placebo, KCit
Experimental
Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCl, KCit, KMgCit, Placebo
Experimental
Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCl, KCit, Placebo, KMgCit
Experimental
Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCl, Placebo, KMgCit, KCit
Experimental
Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCl, Placebo, KCit, KMgCit
Experimental
Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
Placebo, KMgCit, KCit, KCl
Experimental
Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
Placebo, KMgCit, KCl, KCit
Experimental
Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
Placebo, KCit, KMgCit, KCl
Experimental
Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
Placebo, KCit, KCl, KMgCit
Experimental
Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
Placebo, KCl, KMgCit, KCit
Experimental
Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
Placebo, KCl, KCit, KMgCit
Experimental
Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
KCit, KCl, Placebo, KMgCit
KCit, KMgCit, KCl, Placebo
KCit, KMgCit, Placebo, KCl
KCit, Placebo, KCl, KMgCit
KCit, Placebo, KMgCit, KCl
KCl, KCit, KMgCit, Placebo
KCl, KCit, Placebo, KMgCit
KCl, KMgCit, KCit, Placebo
KCl, KMgCit, Placebo, KCit
KCl, Placebo, KCit, KMgCit
KCl, Placebo, KMgCit, KCit
KMgCit, KCit, KCl, Placebo
KMgCit, KCit, Placebo, KCl
KMgCit, KCl, KCit, Placebo
KMgCit, KCl, Placebo, KCit
KMgCit, Placebo, KCit, KCl
KMgCit, Placebo, KCl, KCit
Placebo, KCit, KCl, KMgCit
Placebo, KCit, KMgCit, KCl
Placebo, KCl, KCit, KMgCit
Placebo, KCl, KMgCit, KCit
Placebo, KMgCit, KCit, KCl
Placebo, KMgCit, KCl, KCit
KCl
Potassium citrate powder
Drug
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
KCit, KCl, KMgCit, Placebo
KCit, KCl, Placebo, KMgCit
KCit, KMgCit, KCl, Placebo
KCit, KMgCit, Placebo, KCl
KCit, Placebo, KCl, KMgCit
KCit, Placebo, KMgCit, KCl
KCl, KCit, KMgCit, Placebo
KCl, KCit, Placebo, KMgCit
KCl, KMgCit, KCit, Placebo
KCl, KMgCit, Placebo, KCit
KCl, Placebo, KCit, KMgCit
KCl, Placebo, KMgCit, KCit
KMgCit, KCit, KCl, Placebo
KMgCit, KCit, Placebo, KCl
KMgCit, KCl, KCit, Placebo
KMgCit, KCl, Placebo, KCit
KMgCit, Placebo, KCit, KCl
KMgCit, Placebo, KCl, KCit
Placebo, KCit, KCl, KMgCit
Placebo, KCit, KMgCit, KCl
Placebo, KCl, KCit, KMgCit
Placebo, KCl, KMgCit, KCit
Placebo, KMgCit, KCit, KCl
Placebo, KMgCit, KCl, KCit
KCit
Potassium magnesium citrate powder
Drug
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
KCit, KCl, KMgCit, Placebo
KCit, KCl, Placebo, KMgCit
KCit, KMgCit, KCl, Placebo
KCit, KMgCit, Placebo, KCl
KCit, Placebo, KCl, KMgCit
KCit, Placebo, KMgCit, KCl
KCl, KCit, KMgCit, Placebo
KCl, KCit, Placebo, KMgCit
KCl, KMgCit, KCit, Placebo
KCl, KMgCit, Placebo, KCit
KCl, Placebo, KCit, KMgCit
KCl, Placebo, KMgCit, KCit
KMgCit, KCit, KCl, Placebo
KMgCit, KCit, Placebo, KCl
KMgCit, KCl, KCit, Placebo
KMgCit, KCl, Placebo, KCit
KMgCit, Placebo, KCit, KCl
KMgCit, Placebo, KCl, KCit
Placebo, KCit, KCl, KMgCit
Placebo, KCit, KMgCit, KCl
Placebo, KCl, KCit, KMgCit
Placebo, KCl, KMgCit, KCit
Placebo, KMgCit, KCit, KCl
Placebo, KMgCit, KCl, KCit
KMgCit
Placebo
Drug
1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
KCit, KCl, KMgCit, Placebo
KCit, KCl, Placebo, KMgCit
KCit, KMgCit, KCl, Placebo
KCit, KMgCit, Placebo, KCl
KCit, Placebo, KCl, KMgCit
KCit, Placebo, KMgCit, KCl
KCl, KCit, KMgCit, Placebo
KCl, KCit, Placebo, KMgCit
KCl, KMgCit, KCit, Placebo
KCl, KMgCit, Placebo, KCit
KCl, Placebo, KCit, KMgCit
KCl, Placebo, KMgCit, KCit
KMgCit, KCit, KCl, Placebo
KMgCit, KCit, Placebo, KCl
KMgCit, KCl, KCit, Placebo
KMgCit, KCl, Placebo, KCit
KMgCit, Placebo, KCit, KCl
KMgCit, Placebo, KCl, KCit
Placebo, KCit, KCl, KMgCit
Placebo, KCit, KMgCit, KCl
Placebo, KCl, KCit, KMgCit
Placebo, KCl, KMgCit, KCit
Placebo, KMgCit, KCit, KCl
Placebo, KMgCit, KCl, KCit
Microcystalline cellulose
4 weeks
24-hour Urinary Calcium
4 weeks of treatment
Carotid to Femoral Pulse Wave Velocity
4 weeks
Central Aortic Systolic Blood Pressure
4 weeks
Central Aortic Diastolic Blood Pressure
4 weeks
8 subjects
Received KCl
FG0007 subjects
Received Placebo
FG0007 subjects
COMPLETED
FG00030 subjects
NOT COMPLETED
FG0000 subjects
6 subjects
Received KCl
FG0008 subjects
Received Placebo
FG0009 subjects
COMPLETED
FG00030 subjects
NOT COMPLETED
FG0000 subjects
7 subjects
Received KCl
FG0007 subjects
Received Placebo
FG0007 subjects
COMPLETED
FG00030 subjects
NOT COMPLETED
FG0000 subjects
9 subjects
Received KCl
FG0008 subjects
Received Placebo
FG0007 subjects
COMPLETED
FG00030 subjects
NOT COMPLETED
FG0000 subjects
30
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054± 12
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00016
Male
BG00014
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
Not Hispanic or Latino
BG00026
Unknown or Not Reported
BG0000
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
Asian
BG0000
Native Hawaiian or Other Pacific Islander
BG0000
Black or African American
BG00012
White
BG00018
More than one race
BG0000
Unknown or Not Reported
BG0000
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00030
BMI
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00031± 5
Office Systolic Blood Pressure
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG000125± 11
Office Diastolic Blood Pressure
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG00081± 8
Office Heart Rate
Mean
Standard Deviation
beats per minute
Title
Denominators
Categories
Title
Measurements
BG00072± 11
24-hr Systolic Blood Pressure Average
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG000126± 10
24-hr Diastolic Blood Pressure Average
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG00079± 10
24-hr Heart Rate Average
Mean
Standard Deviation
beats per minute
Title
Denominators
Categories
Title
Measurements
BG00076± 11
24-hr Daytime Systolic Blood Pressure
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG000129± 10
24-hr Daytime Diastolic Blood Pressure
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG00081± 11
24-hr Daytime Heart Rate
Mean
Standard Deviation
beats per minute
Title
Denominators
Categories
Title
Measurements
BG00077± 11
24-hr Nighttime Systolic Blood Pressure
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG000117± 12
24-hr Nighttime Diastolic Blood Pressure
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Title
Measurements
BG00071± 10
24-hr Nighttime Heart Rate
Mean
Standard Deviation
beats per minute
Title
Denominators
Categories
Title
Measurements
BG00070± 11
Serum Calcium
Mean
Standard Deviation
mg/dl
Title
Denominators
Categories
Title
Measurements
BG0009.5± 0.5
Serum Phosphorus
Mean
Standard Deviation
mg/dl
Title
Denominators
Categories
Title
Measurements
BG0003.6± 0.1
Serum Magnesium
Mean
Standard Deviation
mg/dl
Title
Denominators
Categories
Title
Measurements
BG0002.2± 0.3
Serum Sodium
Mean
Standard Deviation
meq/L
Title
Denominators
Categories
Title
Measurements
BG000139± 2
Serum Potassium
Mean
Standard Deviation
meq/L
Title
Denominators
Categories
Title
Measurements
BG0004.2± 0.3
Serum Chloride (meq/L)
Mean
Standard Deviation
meq/L
Title
Denominators
Categories
Title
Measurements
BG000105± 2
Serum Bicarbonate
Mean
Standard Deviation
meq/L
Title
Denominators
Categories
Title
Measurements
BG00023± 2
Serum Urea Nitrogen
Mean
Standard Deviation
mg/dl
Title
Denominators
Categories
Title
Measurements
BG00013.7± 3.5
Serum Creatinine (mg/dl)
Mean
Standard Deviation
mg/dl
Title
Denominators
Categories
Title
Measurements
BG0000.9± 0.2
Serum Albumin
Mean
Standard Deviation
g/dl
Title
Denominators
Categories
Title
Measurements
BG0004.2± 0.6
Serum Parathyroid Hormone
Mean
Standard Deviation
pg/ml
Title
Denominators
Categories
Title
Measurements
BG00059± 31
Serum 1,25-Dihydroxyvitamin D
Mean
Standard Deviation
pg/ml
Title
Denominators
Categories
Title
Measurements
BG00073± 34
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG000127± 11
OG001127± 10
OG002126± 9
OG003129± 13
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.07
Superiority or Other
Primary
24-hour Average Diastolic Blood Pressure
The average diastolic blood pressure over a 24 hour period.
Posted
Mean
Standard Deviation
mmHg
4 weeks
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG00079± 10
OG00178± 9
OG00278± 9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.20
Superiority or Other
Secondary
Office Systolic Blood Pressure
Posted
Mean
Standard Deviation
mmHg
4 weeks
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG000124± 11
OG001125± 13
OG002127± 11
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.16
Superiority or Other
Secondary
Office Diastolic Blood Pressure
Posted
Mean
Standard Deviation
mmHg
4 weeks
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG00081± 9
OG00181± 8
OG00280± 9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.70
Superiority or Other
Secondary
Serum C-terminal Telopeptide (CTX)
Posted
Mean
Standard Deviation
ng/ml
4 weeks
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG0000.46± 0.28
OG0010.46± 0.28
OG0020.45± 0.25
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.42
Superiority or Other
Secondary
24-hour Urinary Calcium
Posted
Mean
Standard Deviation
mg/day
4 weeks of treatment
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG000158± 94
OG001148± 78
OG002160± 92
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.10
Superiority or Other
Secondary
Carotid to Femoral Pulse Wave Velocity
Posted
Mean
Standard Deviation
m/s
4 weeks
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG0008.7± 1.7
OG0018.8± 1.6
OG0028.7± 1.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.64
Superiority or Other
Secondary
Central Aortic Systolic Blood Pressure
Posted
Mean
Standard Deviation
mmHg
4 weeks
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG000121± 11
OG001125± 16
OG002123± 13
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.18
Superiority or Other
Secondary
Central Aortic Diastolic Blood Pressure
Posted
Mean
Standard Deviation
mmHg
4 weeks
ID
Title
Description
OG000
Potassium Magnesium Citrate Powder Phase
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
OG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
OG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
OG003
Placebo Phase
Participants undergoing the Placebo phase of the study.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
Title
Denominators
Categories
Title
Measurements
OG00077± 7
OG00176± 7
OG00277± 9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Mixed Models Analysis
0.12
Superiority or Other
0
30
5
30
EG001
Potassium Citrate Powder Phase
Participants undergoing the Potassium Citrate powder phase of the study.
0
30
5
30
EG002
Potassium Chloride Powder Phase
Participants undergoing the Potassium Chloride powder phase of the study.
0
30
16
30
EG003
Placebo Phase
Participants undergoing the Placebo phase of the study.