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| ID | Type | Description | Link |
|---|---|---|---|
| 2P20GM109036-06A1 | U.S. NIH Grant/Contract | View source |
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The Principal Investigator moved to a new institution and funding for the study was discontinued.
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Chloride | Dietary Supplement | Oral administration of potassium chloride tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Diastolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine 24-hour diastolic BP | 12 weeks |
| Change in Daytime (Awake) Systolic Blood Pressure (BP) From Baseline to 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua D Bundy, PhD, MPH | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University Office of Health Research | New Orleans | Louisiana | 70112 | United States |
The study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Data will be prepared by the study coordinating center and sent to the PO for review prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, the investigators will offer, through a public access website, opportunities for outside investigators to collaborate using complete study data.
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.
Upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Potassium Chloride 30 mmol Per Day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Full Range | mm Hg | 12 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Placebo: Oral administration of inert placebo tablets |
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Study was terminated before outcome assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Mills | Tulane University | 504-988-4749 | kmills4@tulane.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2024 | Jun 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011189 | Potassium Chloride |
| D017419 | Potassium, Dietary |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Eligible participants will be randomly assigned to placebo or 1 of 3 active intervention groups in a 1:1:1:1 ratio.
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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.
|
| Placebo | Other | Oral administration of inert placebo tablets |
|
|
Ambulatory blood pressure monitoring will be used to determine daytime BP
| 12 weeks |
| Change in Daytime (Awake) Diastolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine daytime BP | 12 weeks |
| Change in Nighttime (Asleep) Systolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine nighttime BP | 12 weeks |
| Change in Nighttime (Asleep) Diastolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine nighttime BP | 12 weeks |
| Change in Office Systolic Blood Pressure (BP) From Baseline to 12 Weeks | An automated oscillometric device will be used to determine office BP based on the mean of 6 blood pressure values from two 12-week visits minus the mean of 6 values from 2 baseline visits | 12 weeks |
| Change in Office Diastolic Blood Pressure (BP) From Baseline to 12 Weeks | An automated oscillometric device will be used to determine office BP based on the mean of 6 blood pressure values from two 12-week visits minus the mean of 6 values from 2 baseline visits | 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.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. |
| OG003 | 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. |
|
|
| Secondary | Change in 24-hour Diastolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine 24-hour diastolic BP | Posted | Mean | Full Range | mm Hg | 12 weeks |
|
|
|
| Secondary | Change in Daytime (Awake) Systolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine daytime BP | Posted | Mean | Full Range | mm Hg | 12 weeks |
|
|
|
| Secondary | Change in Daytime (Awake) Diastolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine daytime BP | Posted | Mean | Full Range | mm Hg | 12 weeks |
|
|
|
| Secondary | Change in Nighttime (Asleep) Systolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine nighttime BP | Only one person in the Potassium Chloride 30 mmol per day reached the end of the study. That participant did not have any night (11PM-7AM) ABPM measurements. | Posted | Mean | Full Range | mm Hg | 12 weeks |
|
|
|
| Secondary | Change in Nighttime (Asleep) Diastolic Blood Pressure (BP) From Baseline to 12 Weeks | Ambulatory blood pressure monitoring will be used to determine nighttime BP | Only 1 participants reached the end of the study in the Potassium Chloride 30 mmol per day arm. That participant did not collect any night (11PM-7AM) ABPM measurements. | Posted | Mean | Full Range | mm Hg | 12 weeks |
|
|
|
| Secondary | Change in Office Systolic Blood Pressure (BP) From Baseline to 12 Weeks | An automated oscillometric device will be used to determine office BP based on the mean of 6 blood pressure values from two 12-week visits minus the mean of 6 values from 2 baseline visits | Posted | Mean | Full Range | mm Hg | 12 weeks |
|
|
|
| Secondary | Change in Office Diastolic Blood Pressure (BP) From Baseline to 12 Weeks | An automated oscillometric device will be used to determine office BP based on the mean of 6 blood pressure values from two 12-week visits minus the mean of 6 values from 2 baseline visits | Posted | Mean | Full Range | mm Hg | 12 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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. Potassium Chloride: Oral administration of potassium chloride tablets | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 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. Potassium Chloride: Oral administration of potassium chloride tablets | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | 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. Potassium Chloride: Oral administration of potassium chloride tablets | 0 | 5 | 0 | 5 | 0 | 5 |
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| D017680 |
| Potassium Compounds |