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

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Magnesium citrate

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.