Potassium Intake-response Trial to Control Hypertension

A study testing Potassium Chloride in people with Blood Pressure, run by Tulane University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Blood Pressure
What is being tested?: Potassium Chloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 29 Mar 2023to 3 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Tulane University Office of Health Research
New Orleans, Louisiana, 70112

Other trials in United States

About this study

Read the 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
Being tested: Potassium Chloride, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Potassium ChlorideDietary supplement
Also called Klor-Con
Oral administration of potassium chloride tablets
PlaceboOther
Also called Zeebo
Oral administration of inert placebo tablets

Study groups in NCT05758142
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Potassium Chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 weeks

Secondary outcomes (7)

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
Measured: 12 weeks
Change in Daytime (Awake) Systolic Blood Pressure (BP) From Baseline to 12 Weeks
Ambulatory blood pressure monitoring will be used to determine daytime BP
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 20233 May 2024

First posted7 Mar 2023
Study start29 Mar 2023
Primary completion3 May 2024
Study completion3 May 2024

Why it stopped: The Principal Investigator moved to a new institution and funding for the study was discontinued.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Blood PressureStudies of the same condition, open and under way.
More trials run by Tulane UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Eligible participants will be randomly assigned to placebo or 1 of 3 active intervention groups in a 1:1:1:1 ratio.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05758142
Sponsor's protocol ID: 2022-590
Other IDs: 2P20GM109036-06A1
Acronym: PITCH
Status last verified: Oct 2025
First submitted: 24 Feb 2023
Last updated: 8 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Blood Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Potassium Intake-response Trial to Control Hypertension
ClinicalTrials.gov ID: NCT05758142
Acronym / sponsor ID: PITCH / 2022-590
Conditions: Blood Pressure
Study type: Interventional
Recruitment status: TerminatedReason stopped: The Principal Investigator moved to a new institution and funding for the study was discontinued.
Enrolment: 25 participants (actual)
Lead sponsor: Tulane UniversityUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 29 Mar 2023 (actual)
Primary completion: 3 May 2024 (actual)
Study completion: 3 May 2024 (actual)
First posted: 7 Mar 2023 (actual)
Results: Posted 13 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4
Model description: Eligible participants will be randomly assigned to placebo or 1 of 3 active intervention groups in a 1:1:1:1 ratio.

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboParticipants 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	Dietary Supplement: Potassium ChlorideParticipants 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	Dietary Supplement: Potassium ChlorideParticipants 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	Dietary Supplement: Potassium ChlorideParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Potassium ChlorideAlso: Klor-ConOral administration of potassium chloride tablets	Dietary supplement	Potassium Chloride 30 mmol per day, Potassium Chloride 60 mmol per day, Potassium Chloride 90 mmol per day
PlaceboAlso: ZeeboOral administration of inert placebo tablets	Other	Placebo

Primary outcome

Change in 24-hour Systolic Blood Pressure (BP) From Baseline to 12 Weeks
Time frame: 12 weeks
Ambulatory blood pressure monitoring will be used to determine 24-hour systolic BP

7 secondary outcomes

Change in 24-hour Diastolic Blood Pressure (BP) From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Daytime (Awake) Systolic Blood Pressure (BP) From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Daytime (Awake) Diastolic Blood Pressure (BP) From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Nighttime (Asleep) Systolic Blood Pressure (BP) From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Nighttime (Asleep) Diastolic Blood Pressure (BP) From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Office Systolic Blood Pressure (BP) From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Office Diastolic Blood Pressure (BP) From Baseline to 12 Weeks
Time frame: 12 weeks

Results and safety

Results posted to the registry on 13 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	7	0
Potassium Chloride 30 mmol Per Day	6	0
Potassium Chloride 60 mmol Per Day	7	0
Potassium Chloride 90 mmol Per Day	5	0

Primary outcome: Change in 24-hour Systolic Blood Pressure (BP) From Baseline to 12 Weeks

Time frame: 12 weeks. Mean (Full Range). Unit: mm Hg

Measure	Placebo n = 4	Potassium Chloride 30 mmol Per Day n = 1	Potassium Chloride 60 mmol Per Day n = 2	Potassium Chloride 90 mmol Per Day n = 2
Value	9.0 (-4.2 to 24.2)	-11.0 (-11.0 to -11.0)	1.8 (1.0 to 2.5)	16.2 (10.3 to 22.0)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Potassium Chloride 30 mmol Per Day	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Potassium Chloride 60 mmol Per Day	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Potassium Chloride 90 mmol Per Day	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): Study was terminated before outcome assessments.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Blood Pressure

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Not yet recruiting
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Recruiting
Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults
Aging
Not yet recruiting
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Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joshua D Bundy, PhD, MPH principal investigator

Assistant Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Potassium Chloride in people with Blood Pressure, run by Tulane University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-hour Systolic Blood Pressure (BP) From Baseline to 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05758142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.