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

NCT05145309 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: STU-2021-0912
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• central systolic blood pressure (cSBP)

  4 weeks

• pulse wave velocity

  4 weeks

• augmentation index

  4 weeks

• FGF23

  4 weeks

• klotho

  4 weeks

Study Arms (2)

Potassium Magnesium Citrate (KMgCit) first then Placebo

EXPERIMENTAL

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; Drug: Placebo

Placebo first then KMgCit

EXPERIMENTAL

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; Drug: Placebo

Interventions

KMgCit DRUG

Supplement that provide K, Mg, and citrate

Also known as: Potassium Magnesium Citrate

Placebo first then KMgCit; Potassium Magnesium Citrate (KMgCit) first then Placebo

Placebo DRUG

Power with identical appearance to KMgCit

Placebo first then KMgCit; Potassium Magnesium Citrate (KMgCit) first then Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

potassium-magnesium citrate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study supplement will be dispensed in a blinded manner.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 6, 2021
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2032
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)