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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01074918
• Other study ID #: 012007-080
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-hypertension
• Prehypertension

Intervention

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.
• Potassium Chloride
Potassium Chloride

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.	8 weeks