Potassium Intake-response Trial to Control Hypertension

NCT ID: NCT05758142

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2024-05-03

Brief Summary

The Potassium Intake-response Trial to Control Hypertension (PITCH) will test the intake-response relationship between potassium supplementation and blood pressure, which may inform clinical guidelines on the optimal level of potassium supplementation for blood pressure lowering among adults with elevated blood pressure or hypertension and dietary guidelines for population intake.

Detailed Description

Hypertension is the leading preventable risk factor for cardiovascular disease (CVD) and all-cause mortality, and prevention and treatment of high blood pressure (BP) is crucial for reducing the global burden of CVD.

Nonpharmacological interventions, including dietary interventions, are recommended as the primary approach for prevention and treatment of elevated BP and hypertension in US adults. Observational epidemiological studies have reported an inverse association between dietary potassium intake and BP, and clinical trials have documented that potassium supplementation reduces BP. However, previous clinical trials of potassium supplementation and BP have been limited to comparing one single dose of potassium supplementation (mostly 60 mmol/day or 1173 mg/day) to placebo control. Therefore, the optimal level of dietary intake of potassium in the population is currently unknown. In 2019, the National Academies of Science, Engineering, and Medicine updated the Dietary Reference Intake (DRI) recommendations for potassium intake based on the most current evidence associating potassium intake with CVD outcomes, including BP. Limited evidence precluded the DRI Committee from establishing a Chronic Disease Risk Reduction Intake level. The specific goal of the proposed randomized controlled trial is to study the intake-response effect for 4 levels of potassium supplementation on BP among adults with elevated BP or hypertension (defined as average untreated office systolic BP 120-159 mm Hg and diastolic BP <100 mm Hg). The investigators will test the primary hypothesis that compared with placebo (0 mmol/day potassium supplementation), there is a progressive relationship between increasing doses of oral potassium supplementation (30, 60, and 90 mmol/day or 1173, 2346, 3519 mg/day) and decreasing levels of 24-hour systolic BP from baseline to 12-weeks of follow-up. The investigators will also evaluate effects on daytime (awake) and nighttime (asleep) BP, office systolic and diastolic BP, sodium excretion, and effect mediation and moderation by age, sex, race, central adiposity, baseline urine excretion of sodium and potassium, and change in urine sodium. The results from the proposed trial will fill a critical knowledge gap and may identify the optimal level of potassium supplementation for BP lowering among adults with elevated BP and hypertension. This information can be used to develop dietary guidelines for the prevention and treatment of elevated BP, hypertension, and CVD.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Oral administration of inert placebo tablets

Potassium Chloride 30 mmol per day

Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Potassium Chloride

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of potassium chloride tablets

Potassium Chloride 60 mmol per day

Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Potassium Chloride

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of potassium chloride tablets

Potassium Chloride 90 mmol per day

Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Potassium Chloride

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of potassium chloride tablets

Interventions

Potassium Chloride

Oral administration of potassium chloride tablets

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oral administration of inert placebo tablets

Intervention Type: OTHER

Other Intervention Names

Klor-Con; Zeebo

Eligibility Criteria

Inclusion Criteria

• Men or women aged >18 years of any race/ethnicity
• Elevated BP or hypertension at screening (untreated office systolic BP 120-159 and diastolic BP <100 mm Hg)
• Willing and able to provide informed consent

Exclusion Criteria

• Medical condition in which potassium supplementation is contraindicated: history of heart failure, myocardial infarction, stroke, cardiac arrythmia, chronic kidney disease or estimated glomerular filtration rate <60 ml/min/1.73 m^2, diabetes or non-fasting glucose >200 mg/dL, major depressive disorder (PHQ-9 score ≥15), psychosis, ulcer diseases including esophageal-gastric ulcer, malignancy in the past 5 years, liver disease, organ transplant, Addison's disease (adrenal insufficiency)
• Use of medications which may alter serum potassium levels or in which potassium supplementation is contraindicated: antihypertensive agents, antihistamines, antiparkinson agents, antimuscarinic agents, antipsychotics, muscle relaxants, systemic corticosteroids, or chronic use of non-steroidal anti-inflammatory drugs
• Serum potassium ≥5.0 mEq/L
• Metabolic acidosis
• Consumption of >85th percentile of usual potassium intake among US adults (>3,750 mg/day)
• For women, current pregnancy, breastfeeding, or plans to become pregnant during the study
• Consumption of ≥21 alcoholic beverages per week or consumption of ≥6 beverages per occasion
• Current or planned residence making it difficult to meet trial requirements or travel to the study site
• Current participation in another intervention or pharmaceutical trial
• Unable or unwilling to complete 24-hour BP or urinary sample collection
• Other concerns regarding ability to meet trial requirements, at the discretion of the investigators or staff

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Tulane University

OTHER

Sponsor Role: lead

Responsible Party

Joshua Bundy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua D Bundy, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Tulane University Office of Health Research

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

2P20GM109036-06A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-590

Identifier Type: -

Identifier Source: org_study_id