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Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

This study is currently recruiting participants.
Verified October 2012 by Meta Pharm Development, LLC
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Meta Pharm Development, LLC
ClinicalTrials.gov Identifier:
NCT01682837
First received: September 4, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.


Condition Intervention Phase
Hypertension
 Drug: Potassium chloride powder
Drug: Potassium citrate powder
Drug: Potassium magnesium citrate powder
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meta Pharm Development, LLC:

Primary Outcome Measures:
  • 24-hour blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Office blood pressure [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Serum C-terminal telopeptide (CTX) [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
  • 24-hour urinary calcium [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Carotid to femoral pulse wave velocity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Central aortic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. Subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for a total of 4 weeks.
 Drug: Placebo
1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
Other Name: Microcystalline cellulose
Active Comparator: Potassium chloride powder
Potassium chloride powder, identical in appearance to potassium citrate powder, will contain 20 meq KCl per sachet. 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 a total of 4 weeks.
 Drug: Potassium chloride powder
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks
Other Name: KCl
Active Comparator: Potassium citrate powder
Potassium citrate powder will contain 20 meq KCl per sachet. 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 citrate) per day for a total of 4 weeks.
 Drug: Potassium citrate powder
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
Other Name: KCit
Experimental: Potassium magnesium citrate powder
Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for a total of 4 weeks.
 Drug: Potassium magnesium citrate powder
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
Other Name: KMgCit

Detailed Description:

In this protocol, the investigators want to explore whether KMgCit taken during a customary dietary setting, might serve as a "surrogate" for the DASH diet to lower blood pressure. This study has obvious biomedical importance. Lifestyle modifications are often recommended for pre- or Stage I hypertension. The DASH diet is such a modification that has been shown to be effective. However, this diet is costly and difficult to adhere to long-term. If KMgCit were shown to be effective in lowering blood pressure, it would provide a safe and convenient alternative to the DASH diet.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women > 21 years of age
  • Any Race/Ethnicity
  • Pre- or Stage I hypertension (BP >= 120/80 and <= 159/99)

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 mEq/L for patients on ACE inhibitors or ARBs, serum K > 5.0 for patient not on ACE inhibitors or ARBs)
  • Abnormal liver function test (AST or ALT 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682837

Contacts
Contact: Debbie Arbique, DNP 214-648-2968 debbie.arbique@utsouthwestern.edu

Locations
United States, Texas
Hypertension Clinic - UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Debbie Arbique, DNP     214-648-2968     Debbie.Arbique@UTSouthwestern.edu    
Principal Investigator: Wanpen Vongpatanasin, MD            
Sponsors and Collaborators
Meta Pharm Development, LLC
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Wanpen Vongpatanasin, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Meta Pharm Development, LLC
ClinicalTrials.gov Identifier: NCT01682837     History of Changes
Other Study ID Numbers: LiqKMgCit-1208-01
Study First Received: September 4, 2012
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Citric Acid
Magnesium citrate
Potassium Citrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Chelating Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013