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

Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Pre-hypertension
• Intervention / Treatment: Drug: Potassium, Magnesium, Citrate; Drug: Potassium Chloride

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Potassium Magnesium Citrate	Drug: Potassium, Magnesium, Citrate; 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.
Active Comparator: Potassium Chloride	Drug: Potassium Chloride; Potassium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 23, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Hypertension; Pre-hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: 012007-080