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Not yet recruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether potassium-magnesium citrate can lower blood pressure in African American patients with early or mild high blood pressure. The study product is a powder mixed with water and may offer some of the blood pressure benefits of the DASH diet.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • African American patients with early or mild high blood pressure: a top number of 120–139 mmHg or a bottom number below 90 mmHg.

Who can't join

  • Diabetes or kidney problems shown by a blood creatinine level above 1.4 mg/dL.
  • Any heart disease, such as heart failure or a lasting irregular heartbeat.
  • Regular use of NSAIDs (pain medicines such as ibuprofen), or treatment with water pills, including spironolactone.
  • Acid reflux needing acid-reducing medicine or antacids more than once a week; an ulcer in the stomach or food pipe; or ongoing diarrhea.
  • High blood potassium above 5.0 mmol/L, or a need to take potassium supplements regularly.
  • Liver blood tests called AST or ALT above the normal range.
  • Pregnancy.
  • A history of major depression, bipolar disorder, schizophrenia, or substance abuse.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX