Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

Last updated: October 12, 2023
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

4

Condition

Williams Syndrome

Vascular Diseases

Stress

Treatment

Potassium citrate powder

Placebo

Potassium magnesium Citrate (KMgCit)

Clinical Study ID

NCT02653560
STU 072012-001
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 agentsor 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 onACE 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.

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Potassium citrate powder
Phase: 4
Study Start date:
September 01, 2012
Estimated Completion Date:
January 31, 2015

Study 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.

Connect with a study center

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

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