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Completed

NCT Number: NCT01682837

Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hypertension Clinic - UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

About this study

In this protocol, the investigators want to explore whether KMgCit taken during a customary dietary setting, might serve as a "surrogate" for the Dietary Approaches to Stop Hypertension (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 angiotension-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), serum K > 5.0 meq/L for patient not on ACE inhibitors or ARBs)
  • Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase (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

Treatment and study plan

Potassium chloride powder

Drug

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 names: KCl

Potassium citrate powder

Drug

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 names: KCit

Potassium magnesium citrate powder

Drug

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 names: KMgCit

Placebo

Drug

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Other names: Microcystalline cellulose

Primary outcomes

  1. 24-hour Average Systolic Blood Pressure

    Time frame: 4 weeks

    This is the average systolic blood pressure over a 24 hour period.

  2. 24-hour Average Diastolic Blood Pressure

    Time frame: 4 weeks

    The average diastolic blood pressure over a 24 hour period.

Secondary outcomes

  1. Office Systolic Blood Pressure

    Time frame: 4 weeks

  2. Office Diastolic Blood Pressure

    Time frame: 4 weeks

  3. Serum C-terminal Telopeptide (CTX)

    Time frame: 4 weeks

  4. 24-hour Urinary Calcium

    Time frame: 4 weeks of treatment

  5. Carotid to Femoral Pulse Wave Velocity

    Time frame: 4 weeks

  6. Central Aortic Systolic Blood Pressure

    Time frame: 4 weeks

  7. Central Aortic Diastolic Blood Pressure

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2012
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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