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NCT Number: NCT05145309

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location contact

Ashley Murillo, RN

CONTACT

[email protected]

214-648-5940

Wanpen Vongpatanasin, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

KMgCit

Drug

Supplement that provide K, Mg, and citrate

Other names: Potassium Magnesium Citrate

Placebo

Drug

Power with identical appearance to KMgCit

Primary outcomes

  1. 24-hour systolic blood pressure (24h SBP)

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. central systolic blood pressure (cSBP)

    Time frame: 4 weeks

    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.

  2. pulse wave velocity

    Time frame: 4 weeks

    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.

  3. augmentation index

    Time frame: 4 weeks

    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. FGF23

    Time frame: 4 weeks

    Blood samples will be obtained after 4 weeks of study intervention for measurement of FGF23 concentration, a hormone involved in bone metabolism

  5. klotho

    Time frame: 4 weeks

    Blood samples will be obtained after 4 weeks of study intervention for measurement of klotho concentration, a hormone involved in bone metabolism

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Dec 6, 2021
Registry last updated
Dec 17, 2025

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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