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

NCT ID: NCT01074918

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Pre-hypertension; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Potassium Magnesium Citrate

Group Type: EXPERIMENTAL

Potassium, Magnesium, Citrate

Intervention Type: 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.

Potassium Chloride

Group Type: ACTIVE_COMPARATOR

Potassium Chloride

Intervention Type: DRUG

Potassium Chloride

Interventions

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.

Intervention Type: DRUG

Potassium Chloride

Potassium Chloride

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Orson Moe

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dallas VA Medical Center

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

012007-080

Identifier Type: -

Identifier Source: org_study_id