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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01074918
First received: February 23, 2010
Last updated: March 5, 2010
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Pre-Hypertension
Hypertension
 Drug: Potassium, Magnesium, Citrate
Drug: Potassium Chloride
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.


Estimated Enrollment: 42
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074918

Contacts
Contact: Rubina Muzina 214-857-1909 Rubina.Muzina@va.gov
Contact: Essam Elsayed, MD 214-857-1908 Elsam.Elsayed@va.gov

Locations
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Rubina Muzina     214-857-1909     Rubina.Muzina@va.gov    
Contact: Essam Elsayed, MD     214-857-1908     Essam.Elsayed@va.gov    
UT Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Orson Moe, MD, UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01074918     History of Changes
Other Study ID Numbers: 012007-080
Study First Received: February 23, 2010
Last Updated: March 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Pre-hypertension
Hypertension

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Citric Acid
Magnesium citrate
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013