Potassium Supplementation for Blood Pressure Control

Overseen By Cesar J Jacintho Mortiz, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Hypertension, Heart disease, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether potassium supplements, such as Potassium chloride, can help manage blood pressure and improve blood vessel function, particularly with a high-sodium diet. Researchers will divide participants into groups with different diets to assess how potassium and sodium together affect health. The trial seeks individuals who are generally healthy, have normal blood pressure, and maintain a BMI under 30. It suits those interested in advancing the understanding of diet and blood pressure without current major health issues. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and blood pressure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that potassium chloride supplements can help with low potassium levels. However, they may also cause high potassium levels, known as hyperkalemia, which can be serious, especially for individuals with heart or kidney issues. Understanding these risks is crucial for those considering participation in a trial involving potassium chloride. Discussing potential side effects with a healthcare provider is essential to determine if this treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of potassium supplementation to manage blood pressure. Unlike traditional treatments like ACE inhibitors or beta-blockers, this approach focuses on dietary modification by increasing potassium intake and adjusting sodium levels. The unique angle here is examining how different combinations of potassium and sodium in the diet might impact blood pressure, providing a potentially natural and accessible way to control hypertension. This could open up new avenues for those who prefer dietary changes over medication, offering an alternative strategy that complements existing treatments.

What evidence suggests that potassium supplementation could be effective for blood pressure control?

Research has shown that potassium supplements can help lower blood pressure. One study found that these supplements reduced the systolic blood pressure by 4.48 points and the diastolic by 2.96 points. Another analysis found that people who consumed more potassium had a 24% lower risk of stroke. For those with high blood pressure, potassium proved more effective if they weren't taking other blood pressure medications. While results can vary, these findings suggest that potassium can help manage blood pressure, especially for those who consume a lot of salty foods. This trial will explore different dietary approaches, including moderate and high potassium intake, to assess their impact on blood pressure control. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-45, from any racial or ethnic background, who are in good cardiovascular health. Participants should have a body mass index (BMI) less than 30 and blood pressure below 130/80 mmHg.

Inclusion Criteria

I am either a man or a woman.

All races/ethnicities

BMI < 30 kg/m2

Exclusion Criteria

I have had bleeding in my stomach or intestines before.

I have cancer.

I have an inflammatory condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants consume diets with varying levels of potassium and sodium to assess effects on endothelial function, blood pressure reactivity, and oxidative stress

10 days per diet

3 visits (in-person) for each diet phase

Follow-up

Participants are monitored for safety and effectiveness after dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Potassium chloride supplement

Trial Overview The study is examining if taking potassium chloride supplements can help counteract the negative effects of a high-sodium diet on blood vessel function, blood pressure response, and the autonomic nervous system in healthy adults.

How Is the Trial Designed?

Group I: Moderate potassium/low sodium Experimental Treatment 1 Intervention

Subjects will consume a diet moderation in potassium and low in sodium.

Group II: Moderate potassium/high sodium Experimental Treatment 1 Intervention

Subjects will consume a diet moderation in potassium and high in sodium.

Group III: High potassium/high sodium Experimental Treatment 1 Intervention

Subjects will consume a diet moderation in potassium and high in sodium.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Published Research Related to This Trial

A 6-week double-blind placebo-controlled trial with 59 participants showed that low-dose potassium supplementation (24 mmol/d) significantly reduced mean arterial pressure (MAP) by 7.01 mmHg, systolic blood pressure (SBP) by 7.60 mmHg, and diastolic blood pressure (DBP) by 6.46 mmHg, indicating its efficacy in lowering blood pressure.

The study suggests that this low-dose potassium supplementation, comparable to the potassium found in five servings of fruits and vegetables, can have a substantial impact on blood pressure, similar to that of single-drug therapy for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of low-dose potassium supplementation on blood pressure in apparently healthy volunteers. Naismith, DJ., Braschi, A.[2022]

In a study of 23 patients with mild to moderate essential hypertension, potassium supplementation (60 mmol/day) led to a small but significant 4% reduction in blood pressure after four weeks compared to placebo.

The increase in potassium intake not only lowered blood pressure but also significantly raised urinary potassium excretion, suggesting that dietary potassium could be a beneficial strategy for managing hypertension, potentially reducing the need for medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Moderate supplementation of potassium in essential hypertension]. MacGregor, GA., Smith, SJ., Markandu, ND., et al.[2013]

In a study involving 24 normotensive adult males, neither potassium chloride (KCl) nor potassium citrate had any significant effect on lowering blood pressure, despite confirming potassium intake through urine tests.

The results suggest that neither potassium itself nor the chloride anion plays a crucial role in reducing blood pressure under the conditions tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium effects on blood pressure: is the conjugate anion important? Mullen, JT., O'Connor, DT.[2013]

In a study of 20 patients with mild to moderate essential hypertension, potassium chloride supplementation did not significantly lower blood pressure compared to a placebo, despite increased urinary potassium excretion.

The findings suggest that for patients who are already moderately restricting sodium intake, doubling potassium intake through chloride salt has little to no effect on blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate potassium chloride supplementation in essential hypertension: is it additive to moderate sodium restriction? Smith, SJ., Markandu, ND., Sagnella, GA., et al.[2019]

In a study of 353 participants with slightly elevated diastolic blood pressure, oral potassium chloride supplementation led to a significant increase in urinary potassium levels and a small reduction in diastolic blood pressure by 1.8 mm Hg after 3 months, compared to placebo.

However, the blood pressure reduction effect diminished after 6 months, with no significant impact on systolic blood pressure, indicating that while potassium supplementation may have a short-term benefit, its long-term efficacy in lowering blood pressure is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of potassium supplementation in persons with a high-normal blood pressure. Results from phase I of the Trials of Hypertension Prevention (TOHP). Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Whelton, PK., Buring, J., Borhani, NO., et al.[2019]

A low dose of potassium aspartate (30 mmol/day) significantly reduced both office and 24-hour blood pressure in 104 patients with mild to moderate essential hypertension over four weeks.

The antihypertensive effect was consistent throughout the day and was more pronounced in patients with a higher baseline urinary sodium-to-potassium ratio, indicating a potential mechanism for its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antihypertensive effect of oral potassium aspartate supplementation in mild to moderate arterial hypertension. Franzoni, F., Santoro, G., Carpi, A., et al.[2013]

In a 16-week double-blind trial involving 48 black patients with mildly increased blood pressure, oral potassium supplements (64 mmol daily) significantly reduced both supine and standing blood pressure within just 4 weeks.

The potassium supplements were well-tolerated, with no significant adverse effects reported, suggesting they could be a safe option for managing mild hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-controlled trial of potassium supplements in black patients with mild essential hypertension. Obel, AO.[2022]

In a study of 55 hypertensive patients, potassium supplementation (64 mmol/day) for 4 weeks significantly lowered blood pressure compared to a control period, with notable reductions in home and 24-hour blood pressure measurements.

The effectiveness of potassium supplementation in lowering blood pressure was more pronounced in patients with higher baseline blood pressure and lower potassium intake, suggesting it could be a beneficial treatment for hypertension, albeit with a modest effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of potassium supplementation on office, home, and 24-h blood pressure in patients with essential hypertension. Kawano, Y., Minami, J., Takishita, S., et al.[2019]

In a study involving 20 hypertensive patients, both Slow-K (24 mEq) and K-Tab (30 mEq) were found to be equally effective in maintaining normal serum electrolyte levels, blood pressure, and ECG results over two four-week treatment periods.

No adverse effects were reported for either potassium chloride formulation, and patient acceptance and compliance were similar, indicating that both products can be safely used interchangeably.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic assessment of Slow-K and K-tab potassium chloride formulations in hypertensive patients treated with thiazide diuretics. Skoutakis, VA., Carter, CA., Acchiardo, SR.[2019]

In a study involving 44 normotensive females, potassium supplementation at a dose of 80 mmol/day did not lead to a consistent reduction in blood pressure over two 4-week treatment periods.

Although potassium levels in urine and plasma increased significantly with supplementation, this did not translate to lower blood pressure, suggesting that potassium intake may not have a direct effect on blood pressure in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium supplementation does not lower blood pressure in normotensive women. Barden, AE., Vandongen, R., Beilin, LJ., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7429027/

Potassium Intake and Blood Pressure: A Dose‐Response ... Among those with hypertension, potassium supplementation was on average more effective in lowering BP in participants not using antihypertensive ...

2. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.20545

Blood Pressure Control Should Focus on More Potassium The meta-analysis from Aburto et al also reported a 24% lower risk of stroke (relative risk, 0.76 [95% CI, 0.66–0.89]) with high potassium ...

3. nejm.org nejm.org/doi/full/10.1056/NEJM199003013220901

The Influence of Oral Potassium Chloride on Blood ... We conclude that supplemental potassium chloride does not reduce the need for antihypertensive medication in hypertensive men on a restricted-sodium diet.

4. academic.oup.com academic.oup.com/ckj/article/18/7/sfaf173/8177122

Effect of changes in potassium intake on blood pressure: a ... In subjects without hypertension, potassium supplementation had a modest negative linear effect on BP. In contrast, subjects with hypertension ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527316345363

The effect of potassium supplementation on blood pressure ... Overall, potassium supplementation decreased systolic blood pressure of 4.48 mm Hg (95% CI 3.07–5.90) and diastolic blood pressure of 2.96 mm Hg (1.10–4.82).

6. webmd.com webmd.com/drugs/2/drug-676-7058/potassium-chloride-oral/potassium-extended-release-dispersible-tablet-oral/details

Potassium Chloride (Klor-Con, K-Dur, and others) Potassium chloride can cause a high potassium level (hyperkalemia), which can be serious and may lead to death. This risk is higher in people ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf

K-TAB® (potassium chloride extended-release tablets, USP) The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal ...

8. drugs.com drugs.com/potassium_chloride.html

Potassium Chloride: Uses, Dosage & Side Effects Potassium chloride is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from ...

9. healthy.kaiserpermanente.org healthy.kaiserpermanente.org/health-wellness/drug-encyclopedia/drug.potassium-chloride-er-20-meq-tablet-extended-release.580767

potassium chloride ER 20 mEq tablet,extended release Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems; kidney problems; high levels of potassium in ...