Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans

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, particularly in African Americans (AA). Key components of such a diet are potassium, magnesium, and alkali, each of which has been implicated in lowering blood pressure. In the original IND 116,208, the investigators explored whether potassium-magnesium citrate (KMgCit) as a powder pharmaceutical formulation (dissolved in water before ingestion) could serve as a surrogate for the DASH diet and would lower blood pressure among patients with pre- or Stage I hypertension. Unfortunately, previous studies did not include adequate number of African American patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: KMgCit; Drug: Placebo

Detailed Description

This is a double blind, randomized crossover trial comprising two phases: Placebo Phase (microcrystalline cellulose in water) and KMgCit Phase (KMgCit powder in water) to investigate the use of KMgCit in lowering blood pressure and reducing arterial stiffness. One half of the subjects will undergo the Placebo phase first followed by the KMgCit phase. The other half will undergo the KMgCit phase first followed by the Placebo phase. Each phase is 4 weeks in duration with at least 1 week washout between phases.

Forty-five African American patients of either sex with pre- or Stage I hypertension, with systolic blood pressure of 120-139 mm or diastolic of < 90 mmHg according the 2017 ACC/AHA high BP guideline, will be recruited into the trial, with the expectation that 36 patients would complete both phases of the trial (assuming 20% dropout). They may be AA adult men or women (> 21 years of age). They may be on ACE inhibitor or ARB, but not on spironolactone or diuretic. Excluded will be patients with diabetes mellitus, renal impairment, heart disease, chronic NSAID use, gastrointestinal reflux disease requiring treatment with acid reducing agent of antacid more than once a week, esophageal-gastric ulcer, chronic diarrhea, hyperkalemia, abnormal liver function test, subjects who require potassium supplementation on a regular basis for any reason, pregnancy, history of major depression, bipolar disorder or schizophrenia, and history of substance abuse

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
      • Principal Investigator: Wanpen Vongpatanasin, MD
      • Contact: Ashley Murillo, RN; Phone Number: 214-648-5940; Email: Ashley.Murillo@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

-African American patients with pre- or Stage I hypertension, with systolic blood pressure of 120-139 mm or diastolic BP of < 90 mmHg.

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, including spironolactone
• Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agent or antacid more than once a week,
• Esophageal-gastric ulcer,
• Chronic diarrhea,
• Hyperkalemia (serum K > 5.0 mmol/L),
• Abnormal liver function test (AST or ALT above upper limit of normal range),
• Subjects who require any potassium supplement on a regular basis for any reason,
• Pregnancy,
• History of major depression, bipolar disorder, or schizophrenia, and
• History of substance abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Potassium Magnesium Citrate (KMgCit) first then Placebo; Patients will be asked to take KMgCit ( Sterling Pharmaceutical Services) first for 4 weeks. 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. Then, subjects will be asked to take Placebo packaged in an identical sachet by dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks	Drug: KMgCit; Supplement that provide K, Mg, and citrate; Other Names: Potassium Magnesium Citrate; Drug: Placebo; Power with identical appearance to KMgCit
Experimental: Placebo first then KMgCit; Patients will be asked to take Placebo packaged in an identical sachet by dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks. Then, subjects will be asked to take KMgCit (Sterling Pharmaceutical Services, Dupo, IL) after dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks	Drug: KMgCit; Supplement that provide K, Mg, and citrate; Other Names: Potassium Magnesium Citrate; Drug: Placebo; Power with identical appearance to KMgCit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour systolic blood pressure (24h SBP)	24-hour blood pressures will be recorded using the Spacelab ambulatory oscillometric blood pressure monitor (ABPM) (Spacelabs Medical, Issaquah, WA). Recordings will be made every 20 minutes during the day and every 30 minutes at night. Average data will be calculated for each patient and reported as mmHg.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
central systolic blood pressure (cSBP)	Arterial tonometry and simultaneous ECG will be obtained from the brachial, radial, femoral and carotid arteries noninvasively on the skin using a custom pulse transducer device manufactured by Cardiovascular Engineering, Inc. Carotid systolic BP will be used as central systolic blood pressure. The body surface distances from the suprasternal notch to the brachial (SSN-B), radial (SSN-R), femoral (SSN-F) to calculate carotid to femoral pulse wave velocity. Data will be reported as mmHg.	4 weeks
pulse wave velocity	Arterial tonometry and simultaneous ECG will be obtained from the brachial, radial, femoral and carotid arteries noninvasively on the skin, using a custom pulse transducer device manufactured by Cardiovascular Engineering, Inc. Carotid systolic BP will be used as central systolic blood pressure. The body surface distances from the suprasternal notch to the brachial (SSN-B), radial (SSN-R), femoral (SSN-F) to calculate carotid to femoral pulse wave velocity. Data will be reported as meter/second.	4 weeks
augmentation index	Arterial tonometry and simultaneous ECG will be obtained from the brachial, radial, femoral and carotid arteries noninvasively on the skin, using a custom pulse transducer device manufactured by Cardiovascular Engineering, Inc. Carotid systolic BP will be used as central systolic blood pressure. The computer program will analyze carotid waveform to calculate augmentation index. data will be reported as %.	4 weeks
FGF23	Blood samples will be obtained after 4 weeks of study intervention for measurement of FGF23 concentration, a hormone involved in bone metabolism	4 weeks
klotho	Blood samples will be obtained after 4 weeks of study intervention for measurement of klotho concentration, a hormone involved in bone metabolism	4 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Gastrointestinal Agents; Cathartics; potassium-magnesium citrate
• Other Study ID Numbers: STU-2021-0912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No