Potassium Intake-response Trial to Control Hypertension (PITCH)
Blood Pressure
About this trial
This is an interventional prevention trial for Blood Pressure
Eligibility Criteria
Inclusion Criteria: Men or women aged >18 years of any race/ethnicity Stage 1 hypertension at screening (untreated office systolic BP 130-139 and diastolic BP <90 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 Serum bicarbonate <22 mEq/L 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
Sites / Locations
- Tulane University Office of Health ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo
Potassium Chloride 30 mmol per day
Potassium Chloride 60 mmol per day
Potassium Chloride 90 mmol per day
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.
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.
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.
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.