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

Primary Purpose

Pre-hypertension, Hypertension

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Potassium, Magnesium, Citrate
Potassium Chloride
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pre-hypertension focused on measuring Pre-hypertension, Hypertension

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dallas VA Medical Center
  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Potassium Magnesium Citrate

Potassium Chloride

Arm Description

Outcomes

Primary Outcome Measures

Blood Pressure
We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2010
Last Updated
February 7, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01074918
Brief Title
Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients
Official Title
Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
none enrolled per PI
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-hypertension, Hypertension
Keywords
Pre-hypertension, Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Potassium Magnesium Citrate
Arm Type
Experimental
Arm Title
Potassium Chloride
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Potassium, Magnesium, Citrate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Potassium Chloride
Intervention Description
Potassium Chloride
Primary Outcome Measure Information:
Title
Blood Pressure
Description
We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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