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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am African American with early high blood pressure (120-139/less than 90 mmHg).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24-hour systolic blood pressure (24h SBP)
Secondary outcome measures
FGF23
augmentation index
central systolic blood pressure (cSBP)
+2 moreTrial 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
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,754 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking water pills, including spironolactone.I have a history of major depression, bipolar disorder, or schizophrenia.Your liver function test shows high levels of AST or ALT.I regularly take potassium supplements for my health.My kidney function is impaired with creatinine over 1.4 mg/dL.I have long-term diarrhea.I do not have heart diseases like heart failure or irregular heartbeat.I have an ulcer in my esophagus or stomach.I have diabetes.I am African American with early high blood pressure (120-139/less than 90 mmHg).I take medication for acid reflux more than once a week.Your blood test shows high levels of potassium (more than 5.0 mmol/L).You have a history of using drugs or alcohol in a harmful way.I regularly use anti-inflammatory drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Potassium Magnesium Citrate (KMgCit) first then Placebo
- Group 2: Placebo first then KMgCit
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any known adverse effects to taking KMgCit?
"Given that this is a Phase 2 trial, and thus there is only supportive safety data but no efficacy data, our team has given KMgCit a score of 2."
Answered by AI
Are patients still being accepted for this clinical trial?
"The clinicaltrial.gov website reveals that this trial is not currently looking for patients as it last updated on December 15th, 2022. Although this specific study has completed recruitment, there are 785 other trials that are ongoing and actively recruiting participants."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
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