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

NCT ID: NCT05145309

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-11-15
• Study Completion Date: 2032-12-01

Brief 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, 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.

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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

KMgCit

Intervention Type: DRUG

Supplement that provide K, Mg, and citrate

Placebo

Intervention Type: DRUG

Power with identical appearance to KMgCit

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

Group Type: EXPERIMENTAL

KMgCit

Intervention Type: DRUG

Supplement that provide K, Mg, and citrate

Placebo

Intervention Type: DRUG

Power with identical appearance to KMgCit

Interventions

KMgCit

Supplement that provide K, Mg, and citrate

Intervention Type: DRUG

Placebo

Power with identical appearance to KMgCit

Intervention Type: DRUG

Other Intervention Names

Potassium Magnesium Citrate

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wanpen Vongpatanasin

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Facility Contacts

Ashley Murillo, RN

Role: primary

Ashley.Murillo@UTSouthwestern.edu

214-648-5940

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU-2021-0912

Identifier Type: -

Identifier Source: org_study_id