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 study will test whether potassium supplementation can reduce the deleterious effect of a high sodium diet on blood vessel function, blood pressure reactivity and autonomic nervous system function in apparently healthy adults.

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 potassium supplementation generally safe for humans?

Research shows that potassium supplements, like potassium chloride, are generally safe for humans. Studies involving different formulations and doses found no significant adverse effects, and they were well-tolerated by participants. ^{1 2 3 4 5}

How does potassium chloride supplementation differ from other drugs for blood pressure control?

Potassium chloride supplementation is unique because it focuses on increasing potassium levels in the body, which can help lower blood pressure, especially in people with high-normal or essential hypertension. Unlike some other blood pressure medications, it works by balancing electrolytes rather than directly affecting blood vessels or heart function. ^{1 2 6 7 8}

What evidence supports the effectiveness of potassium chloride supplements for controlling blood pressure?

Research shows that potassium chloride supplements can help lower blood pressure in people with mild hypertension (high blood pressure). In one study, patients taking potassium supplements experienced a significant decrease in blood pressure within four weeks, suggesting that these supplements can be effective in managing mild hypertension. ^{1 2 4 9 10}

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

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]

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]

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 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 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 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]

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 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]

Citations

1. United States 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. [2019]

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

Moderate potassium chloride supplementation in essential hypertension: is it additive to moderate sodium restriction? [2019]

3. England pubmed.ncbi.nlm.nih.gov

The effect of low-dose potassium supplementation on blood pressure in apparently healthy volunteers. [2022]

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

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

5. France pubmed.ncbi.nlm.nih.gov

[Moderate supplementation of potassium in essential hypertension]. [2013]

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

Potassium effects on blood pressure: is the conjugate anion important? [2013]

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

Therapeutic assessment of Slow-K and K-tab potassium chloride formulations in hypertensive patients treated with thiazide diuretics. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Potassium supplementation does not lower blood pressure in normotensive women. [2019]

9. France pubmed.ncbi.nlm.nih.gov

Antihypertensive effect of oral potassium aspartate supplementation in mild to moderate arterial hypertension. [2013]

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

Effects of potassium supplementation on office, home, and 24-h blood pressure in patients with essential hypertension. [2019]