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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

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Potassium chloride powder Drug: Potassium magnesium Citrate (KMgCit) Drug: Potassium citrate powder Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Study Start Date : September 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015


Arm Intervention/treatment
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
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.
Drug: Potassium citrate powder
Other Name: Urocit®-K 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
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.
Drug: Placebo



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653560


Locations
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United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Wanpen Vongpatanasin, MD UT Southwestern Medical Center
Publications of Results:

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Responsible Party: Wanpen Vongpatanasin, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02653560    
Other Study ID Numbers: STU 072012-001
First Posted: January 12, 2016    Key Record Dates
Results First Posted: July 28, 2016
Last Update Posted: July 28, 2016
Last Verified: June 2016
Keywords provided by Wanpen Vongpatanasin, University of Texas Southwestern Medical Center:
Potassium
Magnesium
Citrate
DASH
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Potassium Citrate
Magnesium citrate
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents
Cathartics
Gastrointestinal Agents