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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Potassium Magnesium Citrate for high blood pressure?

Research shows that potassium can help lower blood pressure, and magnesium may also have a small effect. A study found that Potassium Magnesium Citrate reduced a marker of oxidative stress, which is linked to high blood pressure, but its direct impact on blood pressure needs more research. ^{1 2 3 4 5}

Is Potassium Magnesium Citrate safe for humans?

Research on Potassium Magnesium Citrate (KMgCit) suggests it is generally safe for humans, as studies have not reported significant adverse effects. However, more research is needed to fully understand its long-term safety. ^{1 2 3 6 7}

How does the treatment Potassium Magnesium Citrate differ from other treatments for high blood pressure?

Potassium Magnesium Citrate (KMgCit) is unique because it combines potassium and magnesium, which are components of the DASH diet known to reduce blood pressure and oxidative stress. Unlike other treatments, KMgCit specifically targets oxidative stress markers, which may offer additional cardiovascular benefits beyond just lowering blood pressure. ^{2 3 5 6 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect on blood pressure of potassium, calcium, and magnesium in women with low habitual intake. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of potassium and magnesium in essential hypertension: a double-blind, placebo controlled, crossover study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Potassium Magnesium Citrate Supplementation on 24-Hour Ambulatory Blood Pressure and Oxidative Stress Marker in Prehypertensive and Hypertensive Subjects. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Magnesium Supplementation on Blood Pressure: A Meta-Analysis of Randomized Double-Blind Placebo-Controlled Trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

High magnesium diets increase blood pressure and enhance stroke mortality in hypertensive SHRsp rats. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Deleterious effects of high magnesium diets and beneficial effects of high potassium diets in hypertensive stroke-prone rats. [2016]

7. Switzerland pubmed.ncbi.nlm.nih.gov

New oral salt in treatment of high blood pressure. [2005]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectively Prescribing Oral Magnesium Therapy for Hypertension: A Categorized Systematic Review of 49 Clinical Trials. [2023]