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

Conditions

• Hypertension

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Accepted

Interventions

• KMgCit — DRUG
  Supplement that provide K, Mg, and citrate
• Placebo — DRUG
  Power with identical appearance to KMgCit

Study Details

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.

Key Dates

Start date

Nov 15, 2026

Status verified

Dec 2025

Primary completion

Dec 1, 2031

Completion

Dec 1, 2032

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Potassium Magnesium Citrate (KMgCit) first then Placebo
  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
• Experimental: Placebo first then KMgCit
  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

Primary Outcome Measure

24-hour systolic blood pressure (24h SBP) [ Time Frame: 4 weeks ]

Locations (1)

Find similar trials in Dallas, TX

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