Pre-hypertensionPhase 1/2NCT01074918
Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients
A Phase 1/2 study testing Potassium, Magnesium, Citrate and Potassium Chloride in people with Pre-hypertension and Hypertension, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine. Read more about this study
- Who is it for?
- Ages 21 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-hypertension, Hypertension
- What is being tested?
- Potassium, Magnesium, Citrate and Potassium Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 21 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 21 years
- BMI > 18.5 kg/m2 and < 40 kg/m2
- Prehypertension and mild hypertension: BP systolic 120-159 mmHg, diastolic 80-95 mmHg
- Must agree to limit lifestyle changes including: 1) embarking on a new exercise or weight reduction program 2) altering alcohol intake during the trial.
Who cannot join
- Taking blood pressure lowering medication
- Diabetes mellitus
- Renal disease
- Active cardiac disease
- Active liver disease
- Chronic diarrhea
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- Chronic NSAID use
- Active or suspected drug use
- Uncontrolled psychiatric disease
- HIV infection
- Missed more than 20% of clinic visits in the last yr
- Prescription of diuretics for any reason
- A patient taking nutritional supplements including multivitamins that is unwilling to discontinue them,\
- Consumption of greater than 14 alcoholic beverages per week
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dallas VA Medical Center
Dallas, Texas, 75216
UT Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis
The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine.
- Conditions
- Pre-hypertension, Hypertension
- Being tested
- Potassium, Magnesium, Citrate, Potassium Chloride
- Keywords
- Pre-hypertension, Hypertension
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium, Magnesium, CitrateDrug
Potassium MAgnesium Citrate - 30 mEq potassium, 15 mEq Magnesium, 45 mEq Citrate in a powder mixture twice a day, mixed with a glass of water.
Potassium ChlorideDrug
Potassium Chloride
| Study group | Role | What they receive |
|---|---|---|
| Potassium Magnesium Citrate | Experimental | Not described Receives: Drug: Potassium, Magnesium, Citrate |
| Potassium Chloride | Active comparator | Not described Receives: Drug: Potassium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionDec 2012
Why it stopped: none enrolled per PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orson Moe, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074918
- Sponsor's protocol ID
- 012007-080
- Status last verified
- Feb 2019
- First submitted
- 23 Feb 2010
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis
- ClinicalTrials.gov ID
- NCT01074918
- Acronym / sponsor ID
- 012007-080
- Conditions
- Pre-hypertension, Hypertension
- Keywords
- Pre-hypertension, Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: none enrolled per PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Magnesium Citrate | Experimental | Drug: Potassium, Magnesium, Citrate |
| Potassium Chloride | Active comparator | Drug: Potassium Chloride |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 21 years
- BMI > 18.5 kg/m2 and < 40 kg/m2
- Prehypertension and mild hypertension: BP systolic 120-159 mmHg, diastolic 80-95 mmHg
- Must agree to limit lifestyle changes including: 1) embarking on a new exercise or weight reduction program 2) altering alcohol intake during the trial.
Key exclusion criteria (14 listed)
- Taking blood pressure lowering medication
- Diabetes mellitus
- Renal disease
- Active cardiac disease
- Active liver disease
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, Magnesium, CitratePotassium MAgnesium Citrate - 30 mEq potassium, 15 mEq Magnesium, 45 mEq Citrate in a powder mixture twice a day, mixed with a glass of water. | Drug | Potassium Magnesium Citrate |
| Potassium ChloridePotassium Chloride | Drug | Potassium Chloride |
Primary outcome
Blood Pressure
Time frame: 8 weeks
We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Potassium, Magnesium, Citrate and Potassium Chloride in people with Pre-hypertension and Hypertension, run by University of Texas Southwestern Medical Center at 2 sites 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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood Pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2019.