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

Phase 1

Withdrawn

• Conditions: Pre-hypertension; Hypertension
• Interventions: Drug: Potassium, Magnesium, Citrate; Drug: Potassium Chloride

• Registration Number: NCT01074918
• Lead Sponsor: University of Texas Southwestern Medical Center

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 available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Potassium Magnesium Citrate	Potassium, Magnesium, Citrate	-
Potassium Chloride	Potassium Chloride	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States