Potassium-Magnesium Citrate as a Blood Pressure Lowering... | NCT01074918

Studies
Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients

NCT01074918

Sponsor

University of Texas Southwestern Medical Center

Status

Withdrawn

Last Update Posted

Feb 11, 2019Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Pre-hypertension
Hypertension

Interventions

Potassium, Magnesium, Citrate
Potassium Chloride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

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

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

none enrolled per PI

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 23, 2010

First Submission Date that Met QC Criteria

Feb 23, 2010

First Posted Date

Feb 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

Feb 7, 2019

Last Update Posted Date

Feb 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Orson Moe, Professor of Internal Medicine, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine.

Detailed Description

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Potassium Magnesium Citrate	Experimental		Drug: Potassium, Magnesium, Citrate
Potassium Chloride	Active Comparator		Drug: Potassium Chloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Potassium, Magnesium, Citrate	Drug	Potassium MAgnesium Citrate - 30 mEq potassium, 15 mEq Magnesium, 45 mEq Citrate in a powder mixture twice a day, mixed with a glass of water.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Pressure	We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 21 years
BMI > 18.5 kg/m2 and < 40 kg/m2
Prehypertension and mild hypertension: BP systolic 120-159 mmHg, diastolic 80-95 mmHg
Must agree to limit lifestyle changes including: 1) embarking on a new exercise or weight reduction program 2) altering alcohol intake during the trial.

Exclusion Criteria:

Taking blood pressure lowering medication
Diabetes mellitus
Renal disease
Active cardiac disease
Active liver disease
Chronic diarrhea
Chronic NSAID use
Active or suspected drug use
Uncontrolled psychiatric disease
HIV infection
Missed more than 20% of clinic visits in the last yr
Prescription of diuretics for any reason
A patient taking nutritional supplements including multivitamins that is unwilling to discontinue them,\
Consumption of greater than 14 alcoholic beverages per week

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dallas VA Medical Center		Dallas	Texas	75216	United States
UT Southwestern Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D058246	Prehypertension
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C066902	potassium-magnesium citrate
D011189	Potassium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided