Potassium + Water for High Blood Pressure
(PHACKs Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Auburn University
Must not be taking: RAAS blockers, NSAIDs, Beta-blockers, others
Disqualifiers: Pregnancy, Metabolic disease, Cancer, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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).
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.
12345Is 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.
12678How 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.
12789Eligibility 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
I am between 18 and 30 years old.
My BMI is under 35.
+1 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Water and PotassiumExperimental Treatment1 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 consumptionActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kinesiology BuildingAuburn, AL
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Who Is Running the Clinical Trial?
Auburn UniversityLead Sponsor
Indiana UniversityCollaborator
References
Potassium effects on blood pressure: is the conjugate anion important? [2013]Potassium salts, often in the form of KCl, have had variable hypotensive effects in experimental animals and man. The chloride anion has recently been implicated as the hypertensive agent in salt-sensitive hypertension. We therefore hypothesized that non-chloride salts of potassium would have superior hypotensive effects to KCl. In randomized, double-blind fashion, we administered placebo, KCl (75 mmol/day) or potassium citrate (75 mmol/day) to 24 normotensive adult males. In these subjects, neither KCl nor potassium citrate affected blood pressure, despite urinary verification of potassium supplement intake. Thus, in these experimental circumstances, neither potassium nor its conjugate anion were of importance in lowering blood pressure.
Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks. [2020]Use of salt substitutes containing potassium chloride is a potential strategy to reduce sodium intake, increase potassium intake, and thereby lower blood pressure and prevent the adverse consequences of high blood pressure. In this review, we describe the rationale for using potassium-enriched salt substitutes, summarize current evidence on the benefits and risks of potassium-enriched salt substitutes and discuss the implications of using potassium-enriched salt substitutes as a strategy to lower blood pressure. A benefit of salt substitutes that contain potassium chloride is the expected reduction in dietary sodium intake at the population level because of reformulation of manufactured foods or replacement of sodium chloride added to food during home cooking or at the dining table. There is empirical evidence that replacement of sodium chloride with potassium-enriched salt substitutes lowers systolic and diastolic blood pressure (average net Δ [95% CI] in mm Hg: -5.58 [-7.08 to -4.09] and -2.88 [-3.93 to -1.83], respectively). The risks of potassium-enriched salt substitutes include a possible increased risk of hyperkalemia and its principal adverse consequences: arrhythmias and sudden cardiac death, especially in people with conditions that impair potassium excretion such as chronic kidney disease. There is insufficient evidence regarding the effects of potassium-enriched salt substitutes on the occurrence of hyperkalemia. There is a need for additional empirical research on the effect of increasing dietary potassium and potassium-enriched salt substitutes on serum potassium levels and the risk of hyperkalemia, as well as for robust estimation of the population-wide impact of replacing sodium chloride with potassium-enriched salt substitutes.
Moderate potassium chloride supplementation in essential hypertension: is it additive to moderate sodium restriction? [2019]Twenty patients with mild or moderate essential hypertension and not receiving any drug treatment, who had been moderately restricting their sodium intake to around 70 mmol(mEq) a day for at least one month and whose mean blood pressure was then 163/103 mm Hg, were entered into a double blind, randomised crossover study to compare one month's treatment with slow release potassium chloride tablets (64 mmol potassium chloride a day) with one month's treatment with a matching placebo. Mean (SEM) urinary sodium excretion on entry to the study was 68 (6.8) mmol/24 h. Mean urinary potassium excretion increased from 67 (6.9) mmol(mEq)/24 h with placebo to 117 (4.6) mmol/24 h with potassium chloride. Supine and standing systolic and diastolic blood pressures did not change significantly with potassium chloride supplementation when compared with pressures while receiving placebo or before randomisation. In patients who are able moderately to restrict their sodium intake doubling potassium as a chloride salt has little or no effect on blood pressure.
Potassium substitution via the oral route: does its efficacy depend on the anion of the potassium salt? [2019]In an open, randomized study, we investigated the effect of oral potassium chloride (KCl) and of potassium citrate/bicarbonate (K-cit/bic) in 42 patients with hypokalemia (less than or equal to 3.5 mmol/l). In both groups 80 mmol K+ were administered daily. The parameters examined were serum potassium concentration, acid-base status, and urinary electrolyte excretion. Parameters were evaluated on days 0, 2, 4, and 6. With KCl, [K+] increased from 3.2 +/- 0.2 (mean +/- SD) on day 0 to 3.8 +/- 0.4 mmol/l on day 2 (p less than 0.005) and 4.0 +/- 0.5 mmol/l on day 4 (p less than 0.005). On day 6 [K+] was also 4.0 +/- 0.4 mmol/l (p less than 0.005 vs day 0). With K-cit/bic, [K+] increased from 3.2 +/- 0.2 to 3.7 +/- 0.4 on day 2, 3.9 +/- 0.5 on day 4, and 4.1 +/- 0.6 mmol/l on day 6 (all p less than 0.005 vs day 0). The increase of [K+] was not different between the two groups. Blood pH on day 0 was in the normal range in both groups and did not change significantly during the study. There was a decrease of carbon dioxide partial pressure (pCO2) with KCl from 38.7 +/- 4.9 on day 0 to 36.4 +/- 3.6 on day 2 (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
Effects of chlorthalidone on serum and total body potassium in hypertensive patients. [2019]Total body potassium has been estimated in 26 hypertensive patients who were hypokalaemic as a result of long-term chlorthalidone treatment (mean 20.5 months), while they were on chlorthalidone and 4 weeks after this had been discontinued. The mean difference amounted to only 95 mEq (not significant). In 6 additional patients not previously treated with chlorthalidone, serial total body potassium estimations revealed a mean potassium deficiency of 245 mEq after 33 days and of 106 mEq after 100 days. These results suggest that the mechanism causing the initial potassium loss is partly reversed or compensated later on. In patients with uncomplicated hypertension, no significant potassium deficiency was detected during long-term treatment. Eighteen of our patients received 39 mEq potassium chloride supplements daily for 4 weeks; this caused a mean rise in serum potassium from 3.23 mEq/l to 3.38 mEq/l (not significant). Total body potassium did not change at all. We conclude that potassium chloride supplements are not an effective treatment of hypokalaemia in this condition. Correction of the extracellular pH by ammonium chloride in 6 patients on chlorthalidone, who demonstrated a slight metabolic alkalosis, gave rise to a mean increase in plasma potassium from 2.78 mEq/l to 2.96 mEq/l (not significant). The hypokalaemia in hypertensive patients on long-term chlorthalidone treatment cannot be explained by either a potassium deficiency or the change in extracellular pH.
Life-threatening hyperkalemia from nutritional supplements: uncommon or undiagnosed? [2022]Potassium chloride and other potassium compounds are used by the general public as salt substitutes, muscle-building supplements, and panacea. Severe hyperkalemia from oral potassium is extremely rare if kidney function is normal because of potassium adaptation. The oral potassium dose has to be large enough to overcome the normal renal excretory mechanisms to cause severe hyperkalemia. This occurs most commonly in patients with renal impairment or those who take potassium-sparing diuretics, angiotensin receptor blockers, or angiotensin-converting enzyme inhibitors. We present two unique cases of near-fatal hyperkalemia from nutritional supplements containing potassium. The first case was due to salt-substitute intake, whereas the second case was from a muscle-building supplement. Both patients suffered cardiac arrest, but were successfully resuscitated and survived. The acuity of intake and excessive quantity overwhelmed the kidneys' ability for adaptation. Potassium toxicity affects multiple organ systems and manifests in characteristic, acute cardiovascular changes with electrocardiographic abnormalities. Neuromuscular manifestations include general muscular weakness and ascending paralysis may occur, whereas gastrointestinal symptoms manifest as nausea, vomiting, paralytic ileus, and local mucosal necrosis that may lead to perforation. Once an urgent situation has been handled with intravenous push of a 10% calcium salt, short-term measures should be started with agents that cause a transcellular shift of potassium, namely, insulin with glucose, β2-agonist, and NaHCO(3). Patients are unaware of these potentially serious adverse effects, and there are inadequate consumer warnings. Clinicians should be vigilant in monitoring potassium intake from over-the-counter supplements.
The role of potassium in control of blood pressure. [2018]Extra potassium intake has been found to be a determinant of blood pressure for epidemiological and experimental reasons. People with hypertension have a small fall in blood pressure with added potassium. Potassium chloride (48 mmol/day) was given to 36 male patients with high blood pressure; 5 did not comply with therapy. In the entire group of patients, potassium chloride had no significant effect on blood pressure, but prevented the rise in blood pressure and pulse rate produced by posture. In patients with a urinary Na+ excretion less than 75 mmol per 10 mmol creatinine, potassium chloride had no effect on supine blood pressure, but prevented the rise in blood pressure and pulse rate with standing. In those on a high sodium intake, potassium chloride lowered both the systolic and diastolic pressures. In sodium-responsive subjects, potassium chloride prevented the rise in blood pressure induced by sodium chloride but had no significant effect on blood pressure when on a low sodium intake. These results indicate that potassium reduces the rise in blood pressure caused by sodium chloride and reduces the increased sympathetic postural response seen in people on a low sodium intake.
Effect of short-term supplementation of potassium chloride and potassium citrate on blood pressure in hypertensives. [2016]Randomized trials have shown that increasing potassium intake lowers blood pressure. However, most previous trials used potassium chloride, whereas potassium in fruits and vegetables is not a chloride salt. It is unclear whether a nonchloride salt of potassium has a greater or lesser effect on blood pressure compared with potassium chloride. We performed a randomized crossover trial comparing potassium chloride with potassium citrate (96 mmol/d, each for 1 week) in 14 hypertensive individuals. At baseline, blood pressure was 151+/-16/93+/-7 mm Hg with a 24-hour urinary potassium of 81+/-24 mmol. During the randomized crossover part of the study, blood pressure was 140+/-12/88+/-7 mm Hg with potassium chloride (24-hour urinary potassium: 164+/-36 mmol) and 138+/-12/88+/-6 mm Hg with potassium citrate (24-hour urinary potassium: 160+/-33 mmol). These blood pressures were significantly lower compared with that at baseline; however, there was no significant difference in blood pressure between potassium chloride and potassium citrate, mean difference (95% confidence interval): 1.6 (-2.3 to 5.6) mm Hg for systolic and 0.6 (-2.4 to 3.7) mm Hg for diastolic. Our results, in conjunction with the evidence from many previous trials that potassium chloride has a significant blood pressure-lowering effect, suggest that potassium citrate has a similar effect on blood pressure as potassium chloride. These results support other evidence for an increase in potassium intake and indicate that potassium does not need to be given in the form of chloride to lower blood pressure. Increasing the consumption of foods high in potassium is likely to have the same effect on blood pressure as potassium chloride.
Potassium metabolism and therapy in hypertension. [2017]Several studies are available now to highlight the use of K salts in the management of hypertension. Potassium supplements correct diuretic-induced K loss and also lower the blood pressure. However, salt-sensitive hypertension might not respond to K therapy. It acts as a diuretic and reduces plasma volume by inhibiting sodium reabsorption in the renal tubules. It has a vasodilatory effect on the arterioles by directly acting on the smooth muscle cells. Potassium also suppresses plasma renin activity which is not a uniform observation, however; patients who do not respond to K can have a raised plasma renin activity. Potassium might also inhibit neurogenic mechanisms in reducing blood pressure by inhibiting catecholamines. The notion that a low sodium and high K diet can reduce blood pressure without antihypertensive drug therapy is quite interesting because a large number of subjects with subnormal and mild hypertension can benefit from this remedy. However, long term prospective studies would be necessary to generalize the use of K salts in the prevention and treatment of hypertension.