Tests potassium magnesium citrate for high blood pressure in African Americans

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for African American adults with pre-hypertension or Stage I hypertension to test whether potassium-magnesium citrate (KMgCit) lowers blood pressure.

Age

21 years and older

Sex

All sexes can join.

Disease stage

Pre-hypertension or Stage I hypertension, with systolic blood pressure of 120-139 mm or diastolic BP of < 90 mmHg.

Earlier treatment

People treated with diuretics, including spironolactone, cannot join. People on chronic NSAID use cannot join.

Main reasons for not taking part

• Diabetes mellitus
• Renal impairment (serum creatinine > 1.4 mg/dL (124 µmol/L))
• Heart disease such as congestive heart failure or sustained arrhythmia
• Hyperkalemia (serum K > 5.0 mmol/L)
• Pregnancy

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Potassium Magnesium Citrate (KMgCit) first then PlaceboTreatment being tested

  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

  Treatment: KMgCit and Placebo

• Placebo first then KMgCitTreatment being tested

  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

  Treatment: KMgCit and Placebo