Potassium Intake-response Trial to Control Hypertension

NCT05758142 | Terminated DMC

• 2 other identifiers: 2022-5902P20GM109036-06A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour systolic blood pressure (BP) from baseline to 12 weeks

  Ambulatory blood pressure monitoring will be used to determine 24-hour systolic BP

  12 weeks

Secondary Outcomes (7)

• Change in 24-hour diastolic blood pressure (BP) from baseline to 12 weeks

  12 weeks

• Change in daytime (awake) systolic blood pressure (BP) from baseline to 12 weeks

  12 weeks

• Change in daytime (awake) diastolic blood pressure (BP) from baseline to 12 weeks

  12 weeks

• Change in nighttime (asleep) systolic blood pressure (BP) from baseline to 12 weeks

  12 weeks

• Change in nighttime (asleep) diastolic blood pressure (BP) from baseline to 12 weeks

  12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Potassium Chloride 30 mmol per day

ACTIVE COMPARATOR

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.

Dietary Supplement: Potassium Chloride

Potassium Chloride 60 mmol per day

ACTIVE COMPARATOR

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.

Dietary Supplement: Potassium Chloride

Potassium Chloride 90 mmol per day

ACTIVE COMPARATOR

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.

Dietary Supplement: Potassium Chloride

Interventions

Potassium Chloride DIETARY_SUPPLEMENT

Oral administration of potassium chloride tablets

Also known as: Klor-Con

Potassium Chloride 30 mmol per day; Potassium Chloride 60 mmol per day; Potassium Chloride 90 mmol per day

Placebo OTHER

Oral administration of inert placebo tablets

Also known as: Zeebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Tulane University Office of Health Research

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Interventions

Potassium Chloride; Potassium, Dietary

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Potassium Compounds

Study Officials

• Joshua D Bundy, PhD, MPH

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The proposed trial will employ placebo control and blinding of participants and study staff recording participant information. A Bioinformatics and Biostatistics Core will control the randomization and intervention allocation, preserving the blinding of the investigators and study staff in charge of day-to-day operations. Study participants will receive potassium tablets or placebo and will be unaware of their placebo or dosing assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Eligible participants will be randomly assigned to placebo or 1 of 3 active intervention groups in a 1:1:1:1 ratio.

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: March 29, 2023
• Primary Completion: May 3, 2024
• Study Completion: May 3, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data sets will be submitted to the NIH Program Official (PO) no later than 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first.
• Access Criteria: Upon request

Locations

US (1)