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Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

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ClinicalTrials.gov Identifier: NCT02653560
Recruitment Status : Completed
First Posted : January 12, 2016
Results First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Wanpen Vongpatanasin, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE January 12, 2016
Results First Submitted Date  ICMJE May 10, 2016
Results First Posted Date  ICMJE July 28, 2016
Last Update Posted Date July 28, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
24-hour Average Systolic Blood Pressure [ Time Frame: 4 weeks ]
Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
Change in 24-hour blood pressure [ Time Frame: 4 weeks ]
Change in 24 hour blood pressure after each treatment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Official Title  ICMJE Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Brief Summary In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension. Key components of such a diet are potassium, magnesium and alkali, each of which has been implicated in lowering blood pressure. Whether a liquid formulation of potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is unknown.
Detailed Description

The DASH diet is rich in potassium and magnesium. It is also high in alkali content, since the anions are provided mostly by citrate rather than chloride. Considerable data are already available in the literature invoking a protective role on hypertension of potassium, magnesium and alkali.

In this protocol, the investigators want to test the hypothesis that liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation could serve as a surrogate for the DASH diet, and would lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.

Each subject will participate in all four phases, chosen in random order. The four phases will be: Placebo Phase (microcrystalline cellulose in water), Potassium Chloride Phase (potassium chloride powder in water), Potassium Citrate Phase (potassium citrate powder in water), KMgCit Phase (KMgCit powder in water) During each phase, subjects will receive one of the test drugs for 4 weeks, followed by at least 1 week of withdrawal. Change in 24 hr BP, office BP will be measured at baseline and after each phase. Central aortic blood pressure and carotid-femoral pulse wave velocity, -terminal-telopeptide (CTX), 24 hr urine electrolytes will be measured at 4 weeks in each phase.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Potassium chloride powder
  • Drug: Potassium magnesium Citrate (KMgCit)
  • Drug: Potassium citrate powder
    Other Name: Urocit®-K powder
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Potassium magnesium Citrate (KMgCit) arm
    Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks
    Intervention: Drug: Potassium magnesium Citrate (KMgCit)
  • Experimental: Potassium citrate arm
    A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.
    Intervention: Drug: Potassium citrate powder
  • Experimental: Potassium chloride arm
    Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks
    Intervention: Drug: Potassium chloride powder
  • Placebo Comparator: Placebo
    Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2016)
30
Original Actual Enrollment  ICMJE
 (submitted: January 11, 2016)
35
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm
  • Age > 21 years of age

Exclusion Criteria:

  • Diabetes mellitus,
  • Renal impairment (serum creatinine > 1.4 mg/dL),
  • Any heart diseases such as congestive heart failure or sustained arrhythmia,
  • Chronic NSAID use,
  • Treatment with diuretics,
  • Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week,
  • Esophageal-gastric ulcer,
  • Chronic diarrhea
  • Hyperkalemia (serum > 4.6 mmol/L for patients on Angiotensin converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARB), serum K > 5.0 for patient not on ACE inhibitors or ARBs)
  • Liver function test above upper limit of normal range.
  • Subjects who require any potassium supplement on a regular basis from any reasons
  • Pregnancy
  • History of major depression, bipolar disorder, or schizophrenia
  • History of substance abuse.
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653560
Other Study ID Numbers  ICMJE STU 072012-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wanpen Vongpatanasin, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wanpen Vongpatanasin, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2016

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