Potassium Magnesium Citrate for High Blood Pressure

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Diuretics, NSAIDs, Antacids

Disqualifiers: Diabetes, Heart diseases, GERD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement called potassium-magnesium citrate (KMgCit), taken as a drink, can help lower high blood pressure. It tests if this supplement can mimic the effects of a healthy diet known to reduce hypertension, particularly among African Americans. Participants will try both the supplement and a placebo to observe any differences. The trial seeks African American individuals with mild hypertension (systolic blood pressure between 120-139). As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking diuretics and chronic NSAIDs. If you have GERD and need treatment more than once a week, you may also need to stop those medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Potassium Magnesium Citrate (KMgCit) is under investigation for its potential benefits in managing high blood pressure. However, its exact impact on blood pressure remains unclear. Some studies suggest that while potassium may help lower blood pressure, the addition of magnesium or citrate could alter this effect.

Potassium citrate, a component of KMgCit, is often used to prevent certain types of kidney stones. It is generally safe, but there are risks. High levels of potassium in the blood, known as hyperkalemia, can be serious and, in rare cases, life-threatening, particularly for individuals with specific health conditions.

As KMgCit is still being tested for blood pressure management, considering these safety issues is crucial. Participants in clinical trials should be aware of the possible side effects, while also understanding that the treatment is being studied to ensure its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood pressure?

Researchers are excited about Potassium Magnesium Citrate (KMgCit) for high blood pressure because it offers a unique approach compared to standard treatments like ACE inhibitors, beta-blockers, and diuretics. Unlike these options, KMgCit combines potassium and magnesium in a citrate form, which may help in relaxing blood vessels and improving blood flow. This combination not only targets blood pressure but also provides essential minerals that support heart health. Additionally, the treatment is administered as a simple drink, potentially making it easier for patients to incorporate into their daily routine.

What evidence suggests that KMgCit might be an effective treatment for high blood pressure?

Research has shown that potassium magnesium citrate (KMgCit), which participants in this trial will receive, can help lower blood pressure. Specifically, studies have found that it reduces nighttime systolic blood pressure (the top number in a blood pressure reading) compared to a placebo. Other research indicates that KMgCit is more effective than potassium chloride at reversing some side effects of common blood pressure medications. The DASH diet, rich in potassium and magnesium, is known to help control blood pressure, and KMgCit might offer similar benefits. These findings suggest that KMgCit could effectively manage high blood pressure. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I am currently taking water pills, including spironolactone.

Pregnancy

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo Phase

Participants take placebo dissolved in water for 4 weeks

4 weeks

1 visit (in-person) at the start and end of the phase

Washout

Participants undergo a washout period between phases

1 week

KMgCit Phase

Participants take KMgCit dissolved in water for 4 weeks

4 weeks

1 visit (in-person) at the start and end of the phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KMgCit
• Placebo

Trial Overview

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.

How Is the Trial Designed?

Group I: Potassium Magnesium Citrate (KMgCit) first then Placebo Experimental Treatment 2 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 KMgCit Experimental Treatment 2 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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Oral magnesium can effectively lower blood pressure in Uncontrolled Hypertensive patients at doses as low as 240 mg/day, while Untreated Hypertensives require doses greater than 600 mg/day for a significant effect.

In contrast, Controlled Hypertensives and Normotensive individuals do not experience blood pressure reductions with oral magnesium, even at high doses, although other cardiovascular risk factors may improve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectively Prescribing Oral Magnesium Therapy for Hypertension: A Categorized Systematic Review of 49 Clinical Trials. Rosanoff, A., Costello, RB., Johnson, GH.[2023]

A meta-analysis of 34 randomized, double-blind, placebo-controlled trials involving 2028 participants found that magnesium supplementation significantly reduced systolic blood pressure by 2.00 mm Hg and diastolic blood pressure by 1.78 mm Hg over a median duration of 3 months.

The study suggests that a magnesium dose of 300 mg/day for at least 1 month is effective in elevating serum magnesium levels and lowering blood pressure, indicating a potential causal relationship between magnesium supplementation and blood pressure reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Magnesium Supplementation on Blood Pressure: A Meta-Analysis of Randomized Double-Blind Placebo-Controlled Trials. Zhang, X., Li, Y., Del Gobbo, LC., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5021576/

Effects of Potassium Magnesium Citrate Supplementation on ...

We found that KCl supplementation for 4 weeks induced a significant reduction in nighttime SBP compared to placebo (116±12 vs. 121±15 mmHg, respectively, p < ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.21932?doi=10.1161/HYPERTENSIONAHA.123.21932

Potassium Magnesium Citrate Is Superior to ...

Potassium Magnesium Citrate Is Superior to Potassium Chloride in Reversing Metabolic Side Effects of Chlorthalidone | Hypertension.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01074918

Potassium-Magnesium Citrate as a Blood Pressure ...

Study Overview. The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002914916311122

Effects of Potassium Magnesium Citrate Supplementation ...

We found that KCl supplementation for 4 weeks induced a significant reduction in nighttime SBP compared with placebo (116 ± 12 vs 121 ± 15 mm Hg ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37846572/

Potassium Magnesium Citrate Is Superior to ... - PubMed

Potassium Magnesium Citrate Is Superior to Potassium Chloride in Reversing Metabolic Side Effects of Chlorthalidone. Hypertension. 2023 Dec;80(12):2611-2620. ...

6.

mayoclinic.org

mayoclinic.org/drugs-supplements/potassium-citrate-oral-route/description/drg-20074773

Potassium citrate (oral route) - Side effects & dosage

Potassium citrate is used to treat a kidney stone condition called renal tubular acidosis. It is also used to prevent kidney stones that may occur with gout.

7.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.21932

Potassium Magnesium Citrate Is Superior to ...

Potassium Magnesium Citrate Is Superior to Potassium Chloride in Reversing Metabolic Side Effects of Chlorthalidone | Hypertension.

8.

webmd.com

webmd.com/drugs/2/drug-8836-7227/potassium-citrate-oral/potassium-citrate-tablet-oral/details

Potassium Citrate (Urocit-K) - Uses, Side Effects, and More

Potassium citrate can cause a high potassium level (hyperkalemia), which can be serious and may lead to death. This risk is higher in people who ...