Potassium + Water for High Blood Pressure

(PHACKs Trial)

Overseen By Meral A Culver, M.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Must not be taking: RAAS blockers, NSAIDs, Beta-blockers, others

Disqualifiers: Pregnancy, Metabolic disease, Cancer, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking certain medications that don't mix well with potassium supplements, like some blood pressure meds, pain relievers, or blood thinners, you might need to stop them to join this trial. It's best to check with the trial team to see if your specific medications are on the list.

What evidence supports the effectiveness of the drug Potassium chloride for high blood pressure?

There is evidence that using potassium-enriched salt substitutes, which include potassium chloride, can lower blood pressure by reducing sodium intake and increasing potassium intake. However, potassium chloride alone did not show significant effects on blood pressure in some studies. ^{1 2 3 4 5}

Is potassium safe for humans?

Potassium is generally safe for humans, but taking too much, especially in people with kidney problems or those on certain medications, can lead to high potassium levels in the blood, which can be dangerous. This condition, called hyperkalemia, can cause heart problems and other serious health issues. ^{1 2 6 7 8}

How does the drug Potassium differ from other treatments for high blood pressure?

Potassium, whether in the form of potassium chloride or potassium citrate, helps lower blood pressure by increasing potassium intake, which can counteract the effects of high sodium levels. Unlike some other treatments, it can be used as a dietary supplement and may not require prescription medication, making it a more natural option for managing high blood pressure. ^{1 2 7 8 9}

What is the purpose of this trial?

Compared with White Adults, Non-Hispanic Black Adults are at an elevated risk of developing cardiovascular disease (CVD) and end stage chronic-kidney disease (CKD), two of the leading causes of death in the United States. Inadequate hydration status is associated with risk factors for both CVD and CKD. Prior data show that Black individuals are less likely to be adequately hydrated when compared with their White counterparts. Further, socioeconomic factors have been shown to influence hydration practices. Inadequate hydration influences certain hormones that regulate blood volume and impact blood pressure, but increasing potassium intake may provide some positive effects on normalizing these hormones and blood pressure. Black adults, in particular, are more likely to consume less potassium, have inadequate hydration, and tend to have higher blood pressure. As such, there is a critical need for effective strategies to address racial disparities in hydration and resultant health consequences; as well as establish the role of socioeconomic factors contributing to hydration. Therefore, the investigators are seeking to test the investigators' central hypothesis that water with a potassium supplement will improve hydration and cardiovascular health in young White adults (n = 20, 10 females, 10 males), and to a greater extent in young Black Adults (n = 20, 10 females, 10 males. The investigators will assess measures of blood pressure, arterial stiffness, and biomarkers in the urine and blood samples prior to and following a 14-day hydration intervention of 1) bottled water and 2) bottled water with potassium supplementation (2000mg potassium/day).

Research Team

Austin T Robinson, Ph.D.

Principal Investigator

Indiana University

L. Bruce Gladden, Ph.D.

Principal Investigator

Auburn University

Eligibility Criteria

This trial is for young adults aged 18-30 with a BMI below 35, who don't have metabolic diseases like diabetes, kidney or lung issues, cardiovascular conditions, autoimmune disorders, or a history of cancer. They should also have a resting blood pressure no higher than 150/90 mmHg.

Inclusion Criteria

Resting blood pressure no higher than 150/90 mmHg

My BMI is under 35.

I do not have diabetes, kidney, lung, heart diseases, autoimmune conditions, or a history of cancer.

Exclusion Criteria

Currently pregnant or trying to become pregnant

I do not have conditions like hemophilia or take medications like Pradaxa that prevent blood donation.

I am not taking any medication that is unsafe with potassium supplements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Habitual Consumption

Participants are monitored after two weeks of habitual water and potassium intake prior to being assigned into the intervention phase.

2 weeks

1 visit (in-person)

Hydration Intervention

Participants receive 2000mg potassium supplementation/day for 14 days, with assessments of blood pressure, arterial stiffness, and biomarkers in urine and blood samples.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the hydration intervention.

4 weeks

Treatment Details

Interventions

• Potassium

Trial Overview The study tests if drinking water with added potassium (2000mg/day) can improve hydration and heart health better in Black adults compared to White adults. It involves taking urine and blood samples before and after a two-week period of this hydration strategy.

Participant Groups

Group I: Water and Potassium Experimental Treatment 1 Intervention

N=40, 20 males, 20 females. Following the two-week habitual run-in period, this group will receive 2000mg potassium supplementation/day for 14 days. This will be achieved by taking capsules filled with potassium chloride powder.

Group II: Habitual consumption Active Control 1 Intervention

N=40, 20 males, 20 females. All participants will be monitored after two weeks of habitual water and potassium prior to being assigned into two weeks of water and potassium.

Potassium is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Potassium chloride for:

• Hypokalemia
• Cardiovascular disease prevention

Approved in European Union as Potassium chloride for:

• Hypokalemia
• Electrolyte imbalance

Approved in Canada as Potassium citrate for:

• Hypokalemia
• Kidney stone prevention

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Findings from Research

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]

Potassium-enriched salt substitutes can significantly lower blood pressure, with average reductions of -5.58 mm Hg for systolic and -2.88 mm Hg for diastolic pressure, making them a promising strategy for reducing sodium intake and improving heart health.

However, there is a risk of hyperkalemia, which can lead to serious heart issues, particularly in individuals with kidney problems, highlighting the need for more research on the safety and population-wide effects of these substitutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks. Greer, RC., Marklund, M., Anderson, CAM., et al.[2020]

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 42 patients with low potassium levels, both oral potassium chloride (KCl) and potassium citrate/bicarbonate (K-cit/bic) effectively increased serum potassium levels from an average of 3.2 mmol/l to around 4.0 mmol/l over 6 days, showing similar efficacy between the two treatments.

The study found no significant changes in blood pH, indicating that both treatments are safe in maintaining acid-base balance while correcting hypokalemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium substitution via the oral route: does its efficacy depend on the anion of the potassium salt? Meyer-Lehnert, H., Evers, WM., Krück, F.[2019]

In a study of 26 hypertensive patients on long-term chlorthalidone treatment, no significant potassium deficiency was found, suggesting that potassium loss may be compensated over time.

Potassium chloride supplements did not effectively treat hypokalaemia in these patients, as total body potassium remained unchanged and serum potassium levels showed only a minor, non-significant increase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of chlorthalidone on serum and total body potassium in hypertensive patients. Leemhuis, MP., van Damme, KJ., Struyvenberg, A.[2019]

Severe hyperkalemia, or high potassium levels, from oral potassium supplements is rare in healthy individuals but can occur in those with kidney issues or on certain medications; two cases of near-fatal hyperkalemia were reported from potassium-containing supplements, leading to cardiac arrest.

Potassium toxicity can cause serious health issues, including cardiovascular changes, muscle weakness, and gastrointestinal problems, highlighting the need for better consumer awareness and monitoring of potassium intake from over-the-counter supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life-threatening hyperkalemia from nutritional supplements: uncommon or undiagnosed? John, SK., Rangan, Y., Block, CA., et al.[2022]

In a study of 36 male patients with high blood pressure, potassium chloride supplementation did not significantly lower overall blood pressure but effectively prevented increases in blood pressure and pulse rate when changing posture, particularly in those with low sodium excretion.

For patients with high sodium intake, potassium chloride was found to lower both systolic and diastolic blood pressure, suggesting that potassium can mitigate the blood pressure-raising effects of sodium chloride.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of potassium in control of blood pressure. Morgan, T., Teow, BH., Myers, J.[2018]

A randomized crossover trial involving 14 hypertensive individuals found that both potassium chloride and potassium citrate significantly lowered blood pressure compared to baseline measurements, indicating that increasing potassium intake is beneficial for hypertension.

There was no significant difference in blood pressure reduction between potassium chloride and potassium citrate, suggesting that potassium can be effective in non-chloride forms, supporting the idea that consuming potassium-rich foods may similarly help lower blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of short-term supplementation of potassium chloride and potassium citrate on blood pressure in hypertensives. He, FJ., Markandu, ND., Coltart, R., et al.[2016]

Potassium salts can effectively manage hypertension by correcting potassium loss from diuretics, lowering blood pressure through diuretic effects, and promoting vasodilation in blood vessels.

A low sodium and high potassium diet may help reduce blood pressure in many individuals with mild hypertension, but further long-term studies are needed to confirm the safety and efficacy of potassium salts as a standard treatment for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium metabolism and therapy in hypertension. Singh, RB., Singh, NK.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks. [2020]

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

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

4. Germany pubmed.ncbi.nlm.nih.gov

Potassium substitution via the oral route: does its efficacy depend on the anion of the potassium salt? [2019]

5. Sweden pubmed.ncbi.nlm.nih.gov

Effects of chlorthalidone on serum and total body potassium in hypertensive patients. [2019]

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

Life-threatening hyperkalemia from nutritional supplements: uncommon or undiagnosed? [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

The role of potassium in control of blood pressure. [2018]

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

Effect of short-term supplementation of potassium chloride and potassium citrate on blood pressure in hypertensives. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Potassium metabolism and therapy in hypertension. [2017]