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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orson Moe, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01074918
First received: February 23, 2010
Last updated: December 10, 2013
Last verified: December 2013

February 23, 2010
December 10, 2013
September 2009
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01074918 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Pre-hypertension
  • Hypertension
  • 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.
  • Drug: Potassium Chloride
    Potassium Chloride
  • Experimental: Potassium Magnesium Citrate
    Intervention: Drug: Potassium, Magnesium, Citrate
  • Active Comparator: Potassium Chloride
    Intervention: Drug: Potassium Chloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 95 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01074918
012007-080
Yes
Orson Moe, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Not Provided
University of Texas Southwestern Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP