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Alkali

Potassium Magnesium Citrate for High Blood Pressure

Phase 2

Waitlist Available

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Treatment with diuretics, including spironolactone

History of major depression, bipolar disorder, or schizophrenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial sought to enroll a racially diverse patient population.

Who is the study for?

This trial is for African American individuals with early-stage high blood pressure (systolic BP of 120-139 mmHg or diastolic BP under 90 mmHg). It's not open to those who are pregnant, have kidney issues, take certain heartburn medications regularly, use chronic NSAIDs or diuretics, have liver problems, need potassium supplements, suffer from diabetes or serious heart conditions.

What is being tested?

The study tests if a powder form of Potassium Magnesium Citrate (KMgCit), dissolved in water and ingested, can help control high blood pressure as an alternative to the DASH diet. Participants will either receive KMgCit or a placebo without knowing which one they're taking.

What are the potential side effects?

Possible side effects may include digestive discomfort due to the ingestion of KMgCit solution. There could also be risks associated with changes in blood pressure levels and potential imbalances in electrolytes like potassium.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am African American with early high blood pressure (120-139/less than 90 mmHg).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking water pills, including spironolactone.

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I have a history of major depression, bipolar disorder, or schizophrenia.

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I regularly take potassium supplements for my health.

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My kidney function is impaired with creatinine over 1.4 mg/dL.

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I have long-term diarrhea.

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I have an ulcer in my esophagus or stomach.

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I do not have heart diseases like heart failure or irregular heartbeat.

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I have diabetes.

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I take medication for acid reflux more than once a week.

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I regularly use anti-inflammatory drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24-hour systolic blood pressure (24h SBP)

Secondary study objectives

FGF23

augmentation index

central systolic blood pressure (cSBP)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Potassium Magnesium Citrate (KMgCit) first then PlaceboExperimental Treatment2 Interventions

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

Group II: Placebo first then KMgCitExperimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 11Eligibility criteria met