HypertensionPhase 4NCT02653560
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
A Phase 4 study testing Potassium chloride powder, Potassium magnesium Citrate (KMgCit) and Potassium citrate powder in people with Hypertension, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Potassium chloride powder, Potassium magnesium Citrate (KMgCit) and Potassium citrate powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2015
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm
- Age > 21 years of age
Who cannot join
- Diabetes mellitus,
- Renal impairment (serum creatinine > 1.4 mg/dL),
- Any heart diseases such as congestive heart failure or sustained arrhythmia,
- Chronic NSAID use,
- Treatment with diuretics,
- Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week,
Show all 14Show fewer
- Esophageal-gastric ulcer,
- Chronic diarrhea
- Hyperkalemia (serum > 4.6 mmol/L for patients on Angiotensin converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARB), serum K > 5.0 for patient not on ACE inhibitors or ARBs)
- Liver function test above upper limit of normal range.
- Subjects who require any potassium supplement on a regular basis from any reasons
- Pregnancy
- History of major depression, bipolar disorder, or schizophrenia
- History of substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension. Key components of such a diet are potassium, magnesium and alkali, each of which has been implicated in lowering blood pressure. Whether a liquid formulation of potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is unknown.
Read the detailed description
The DASH diet is rich in potassium and magnesium. It is also high in alkali content, since the anions are provided mostly by citrate rather than chloride. Considerable data are already available in the literature invoking a protective role on hypertension of potassium, magnesium and alkali.
In this protocol, the investigators want to test the hypothesis that liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation could serve as a surrogate for the DASH diet, and would lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.
Each subject will participate in all four phases, chosen in random order. The four phases will be: Placebo Phase (microcrystalline cellulose in water), Potassium Chloride Phase (potassium chloride powder in water), Potassium Citrate Phase (potassium citrate powder in water), KMgCit Phase (KMgCit powder in water) During each phase, subjects will receive one of the test drugs for 4 weeks, followed by at least 1 week of withdrawal. Change in 24 hr BP, office BP will be measured at baseline and after each phase. Central aortic blood pressure and carotid-femoral pulse wave velocity, -terminal-telopeptide (CTX), 24 hr urine electrolytes will be measured at 4 weeks in each phase.
- Conditions
- Hypertension
- Being tested
- Potassium chloride powder, Potassium magnesium Citrate (KMgCit), Potassium citrate powder, Placebo
- Keywords
- Potassium, Magnesium, Citrate, DASH
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium chloride powderDrug
Potassium magnesium Citrate (KMgCit)Drug
Potassium citrate powderDrug
Also called Urocit®-K powder
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Potassium magnesium Citrate (KMgCit) arm | Experimental | Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks Receives: Drug: Potassium magnesium Citrate (KMgCit) |
| Potassium citrate arm | Experimental | A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks. Receives: Drug: Potassium citrate powder |
| Potassium chloride arm | Experimental | Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks Receives: Drug: Potassium chloride powder |
| Placebo | Placebo comparator | Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Average Systolic Blood Pressure
Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startSep 2012
- Primary completionJan 2015
- Study completionJan 2015
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.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanpen Vongpatanasin, University of Texas Southwestern Medical Center
- Investigators
- Wanpen Vongpatanasin, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653560
- Sponsor's protocol ID
- STU 072012-001
- Status last verified
- Oct 2023
- First submitted
- 8 Jan 2016
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
He FJ, Markandu ND, Coltart R, Barron J, MacGregor GA. Effect of short-term supplementation of potassium chloride and potassium citrate on blood pressure in hypertensives. Hypertension. 2005 Apr;45(4):571-4. doi: 10.1161/01.HYP.0000158264.36590.19. Epub 2005 Feb 21.
PubMed 15723964Conlin PR, Erlinger TP, Bohannon A, Miller ER 3rd, Appel LJ, Svetkey LP, Moore TJ. The DASH diet enhances the blood pressure response to losartan in hypertensive patients. Am J Hypertens. 2003 May;16(5 Pt 1):337-42. doi: 10.1016/s0895-7061(03)00056-6.
PubMed 12745193He FJ, Marciniak M, Carney C, Markandu ND, Anand V, Fraser WD, Dalton RN, Kaski JC, MacGregor GA. Effects of potassium chloride and potassium bicarbonate on endothelial function, cardiovascular risk factors, and bone turnover in mild hypertensives. Hypertension. 2010 Mar;55(3):681-8. doi: 10.1161/HYPERTENSIONAHA.109.147488. Epub 2010 Jan 18.
PubMed 20083724Lin PH, Aickin M, Champagne C, Craddick S, Sacks FM, McCarron P, Most-Windhauser MM, Rukenbrod F, Haworth L; Dash-Sodium Collaborative Research Group. Food group sources of nutrients in the dietary patterns of the DASH-Sodium trial. J Am Diet Assoc. 2003 Apr;103(4):488-96. doi: 10.1053/jada.2003.50065.
PubMed 12669013Lind L, Lithell H, Pollare T, Ljunghall S. Blood pressure response during long-term treatment with magnesium is dependent on magnesium status. A double-blind, placebo-controlled study in essential hypertension and in subjects with high-normal blood pressure. Am J Hypertens. 1991 Aug;4(8):674-9. doi: 10.1093/ajh/4.8.674.
PubMed 1930849China Salt Substitute Study Collaborative Group. Salt substitution: a low-cost strategy for blood pressure control among rural Chinese. A randomized, controlled trial. J Hypertens. 2007 Oct;25(10):2011-8. doi: 10.1097/HJH.0b013e3282b9714b.
PubMed 17885542Sellmeyer DE, Schloetter M, Sebastian A. Potassium citrate prevents increased urine calcium excretion and bone resorption induced by a high sodium chloride diet. J Clin Endocrinol Metab. 2002 May;87(5):2008-12. doi: 10.1210/jcem.87.5.8470.
PubMed 11994333
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
- ClinicalTrials.gov ID
- NCT02653560
- Acronym / sponsor ID
- STU 072012-001
- Conditions
- Hypertension
- Keywords
- Potassium, Magnesium, Citrate, DASH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 28 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension. Key components of such a diet are potassium, magnesium and alkali, each of which has been implicated in lowering blood pressure. Whether a liquid formulation of potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is unknown.
Detailed description
The DASH diet is rich in potassium and magnesium. It is also high in alkali content, since the anions are provided mostly by citrate rather than chloride. Considerable data are already available in the literature invoking a protective role on hypertension of potassium, magnesium and alkali.
In this protocol, the investigators want to test the hypothesis that liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation could serve as a surrogate for the DASH diet, and would lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.
Each subject will participate in all four phases, chosen in random order. The four phases will be: Placebo Phase (microcrystalline cellulose in water), Potassium Chloride Phase (potassium chloride powder in water), Potassium Citrate Phase (potassium citrate powder in water), KMgCit Phase (KMgCit powder in water) During each phase, subjects will receive one of the test drugs for 4 weeks, followed by at least 1 week of withdrawal. Change in 24 hr BP, office BP will be measured at baseline and after each phase. Central aortic blood pressure and carotid-femoral pulse wave velocity, -terminal-telopeptide (CTX), 24 hr urine electrolytes will be measured at 4 weeks in each phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Potassium magnesium Citrate (KMgCit) arm | Experimental | Drug: Potassium magnesium Citrate (KMgCit)Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks |
| Potassium citrate arm | Experimental | Drug: Potassium citrate powderA special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks. |
| Potassium chloride arm | Experimental | Drug: Potassium chloride powderPotassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm
- Age > 21 years of age
Key exclusion criteria (14 listed)
- Diabetes mellitus,
- Renal impairment (serum creatinine > 1.4 mg/dL),
- Any heart diseases such as congestive heart failure or sustained arrhythmia,
- Chronic NSAID use,
- Treatment with diuretics,
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 chloride powder | Drug | Potassium chloride arm |
| Potassium magnesium Citrate (KMgCit) | Drug | Potassium magnesium Citrate (KMgCit) arm |
| Potassium citrate powderAlso: Urocit®-K powder | Drug | Potassium citrate arm |
| Placebo | Drug | Placebo |
Primary outcome
24-hour Average Systolic Blood Pressure
Time frame: 4 weeks
Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15723964He FJ, Markandu ND, Coltart R, Barron J, MacGregor GA. Effect of short-term supplementation of potassium chloride and potassium citrate on blood pressure in hypertensives. Hypertension. 2005 Apr;45(4):571-4. doi: 10.1161/01.HYP.0000158264.36590.19. Epub 2005 Feb 21.
- Results publication: PubMed 12745193Conlin PR, Erlinger TP, Bohannon A, Miller ER 3rd, Appel LJ, Svetkey LP, Moore TJ. The DASH diet enhances the blood pressure response to losartan in hypertensive patients. Am J Hypertens. 2003 May;16(5 Pt 1):337-42. doi: 10.1016/s0895-7061(03)00056-6.
- Results publication: PubMed 20083724He FJ, Marciniak M, Carney C, Markandu ND, Anand V, Fraser WD, Dalton RN, Kaski JC, MacGregor GA. Effects of potassium chloride and potassium bicarbonate on endothelial function, cardiovascular risk factors, and bone turnover in mild hypertensives. Hypertension. 2010 Mar;55(3):681-8. doi: 10.1161/HYPERTENSIONAHA.109.147488. Epub 2010 Jan 18.
- Results publication: PubMed 12669013Lin PH, Aickin M, Champagne C, Craddick S, Sacks FM, McCarron P, Most-Windhauser MM, Rukenbrod F, Haworth L; Dash-Sodium Collaborative Research Group. Food group sources of nutrients in the dietary patterns of the DASH-Sodium trial. J Am Diet Assoc. 2003 Apr;103(4):488-96. doi: 10.1053/jada.2003.50065.
- Results publication: PubMed 1930849Lind L, Lithell H, Pollare T, Ljunghall S. Blood pressure response during long-term treatment with magnesium is dependent on magnesium status. A double-blind, placebo-controlled study in essential hypertension and in subjects with high-normal blood pressure. Am J Hypertens. 1991 Aug;4(8):674-9. doi: 10.1093/ajh/4.8.674.
- Results publication: PubMed 17885542China Salt Substitute Study Collaborative Group. Salt substitution: a low-cost strategy for blood pressure control among rural Chinese. A randomized, controlled trial. J Hypertens. 2007 Oct;25(10):2011-8. doi: 10.1097/HJH.0b013e3282b9714b.
- Results publication: PubMed 11994333Sellmeyer DE, Schloetter M, Sebastian A. Potassium citrate prevents increased urine calcium excretion and bone resorption induced by a high sodium chloride diet. J Clin Endocrinol Metab. 2002 May;87(5):2008-12. doi: 10.1210/jcem.87.5.8470.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Wanpen Vongpatanasin, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Potassium chloride powder, Potassium magnesium Citrate (KMgCit) and Potassium citrate powder in people with Hypertension, run by University of Texas Southwestern Medical Center 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 2 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: finished, as of the sponsor's last update on 16 Oct 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2016). 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?
24-hour Average Systolic Blood Pressure (time frame: 4 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 NCT02653560, which also lists 7 linked publications.
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 16 Oct 2023.