Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans
University of Texas Southwestern Medical Center
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.
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,…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
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 \>…
Interventions
- DrugKMgCit
Supplement that provide K, Mg, and citrate
- DrugPlacebo
Power with identical appearance to KMgCit
Location
- University of Texas Southwestern Medical CenterDallas, Texas