HypertensionPhase 2NCT01682837
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
A Phase 2 study testing Potassium chloride powder, Potassium citrate powder and Potassium magnesium citrate powder in people with Hypertension, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood pressure among patients with pre- or Stage I hypertension on their customary diet. 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 citrate powder and Potassium magnesium citrate powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2015
- Phase
- Phase 2
- 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
- Men or women > 21 years of age
- Any Race/Ethnicity
- Pre- or Stage I hypertension (BP >= 120/80 and <= 159/99)
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 13Show fewer
- Esophageal-gastric ulcer
- Chronic diarrhea
- Hyperkalemia (serum > 4.6 meq/L for patients on angiotension-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), serum K > 5.0 meq/L for patient not on ACE inhibitors or ARBs)
- Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase (ALT) 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hypertension Clinic - UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.
Read the detailed description
In this protocol, the investigators want to explore whether KMgCit taken during a customary dietary setting, might serve as a "surrogate" for the Dietary Approaches to Stop Hypertension (DASH) diet to lower blood pressure. This study has obvious biomedical importance. Lifestyle modifications are often recommended for pre- or Stage I hypertension. The DASH diet is such a modification that has been shown to be effective. However, this diet is costly and difficult to adhere to long-term. If KMgCit were shown to be effective in lowering blood pressure, it would provide a safe and convenient alternative to the DASH diet.
- Conditions
- Hypertension
- Being tested
- Potassium chloride powder, Potassium citrate powder, Potassium magnesium citrate powder, Placebo
- 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
Also called KCl
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks
Potassium citrate powderDrug
Also called KCit
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
Potassium magnesium citrate powderDrug
Also called KMgCit
1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
PlaceboDrug
Also called Microcystalline cellulose
1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| KMgCit, KCit, KCl, Placebo | Experimental | Participants who received study drug in the order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KMgCit, KCit, Placebo, KCl | Experimental | Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KMgCit, KCl, KCit, Placebo | Experimental | Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KMgCit, KCl, Placebo, KCit | Experimental | Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KMgCit, Placebo, KCit, KCl | Experimental | Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KMgCit, Placebo, KCl, KCit | Experimental | Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCit, KMgCit, KCl, Placebo | Experimental | Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCit, KMgCit, Placebo, KCl | Experimental | Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCit, KCl, KMgCit, Placebo | Experimental | Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCit, KCl, Placebo, KMgCit | Experimental | Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCit, Placebo, KMgCit, KCl | Experimental | Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCit, Placebo, KCl, KMgCit | Experimental | Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCl, KMgCit, KCit, Placebo | Experimental | Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCl, KMgCit, Placebo, KCit | Experimental | Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCl, KCit, KMgCit, Placebo | Experimental | Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCl, KCit, Placebo, KMgCit | Experimental | Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCl, Placebo, KMgCit, KCit | Experimental | Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| KCl, Placebo, KCit, KMgCit | Experimental | Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| Placebo, KMgCit, KCit, KCl | Experimental | Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| Placebo, KMgCit, KCl, KCit | Experimental | Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| Placebo, KCit, KMgCit, KCl | Experimental | Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| Placebo, KCit, KCl, KMgCit | Experimental | Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| Placebo, KCl, KMgCit, KCit | Experimental | Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo |
| Placebo, KCl, KCit, KMgCit | Experimental | Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Receives: Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; 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
This is the average systolic blood pressure over a 24 hour period.
Measured: 4 weeks
24-hour Average Diastolic Blood Pressure
The average diastolic blood pressure over a 24 hour period.
Measured: 4 weeks
Secondary outcomes (7)
Office Systolic Blood Pressure
Measured: 4 weeks
Office Diastolic Blood Pressure
Measured: 4 weeks
Serum C-terminal Telopeptide (CTX)
Measured: 4 weeks
24-hour Urinary Calcium
Measured: 4 weeks of treatment
Carotid to Femoral Pulse Wave Velocity
Measured: 4 weeks
Central Aortic Systolic Blood Pressure
Measured: 4 weeks
Central Aortic Diastolic Blood Pressure
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 posted11 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2015
- Study completionMar 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 (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanpen Vongpatanasin, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682837
- Sponsor's protocol ID
- LiqKMgCit-1208-01
- Status last verified
- Mar 2017
- First submitted
- 4 Sep 2012
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vongpatanasin W, Peri-Okonny P, Velasco A, Arbique D, Wang Z, Ravikumar P, Adams-Huet B, Moe OW, Pak CYC. Effects of Potassium Magnesium Citrate Supplementation on 24-Hour Ambulatory Blood Pressure and Oxidative Stress Marker in Prehypertensive and Hypertensive Subjects. Am J Cardiol. 2016 Sep 15;118(6):849-853. doi: 10.1016/j.amjcard.2016.06.041. Epub 2016 Jun 28.
PubMed 27448942
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. 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
- NCT01682837
- Acronym / sponsor ID
- LiqKMgCit-1208-01
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.
Detailed description
In this protocol, the investigators want to explore whether KMgCit taken during a customary dietary setting, might serve as a "surrogate" for the Dietary Approaches to Stop Hypertension (DASH) diet to lower blood pressure. This study has obvious biomedical importance. Lifestyle modifications are often recommended for pre- or Stage I hypertension. The DASH diet is such a modification that has been shown to be effective. However, this diet is costly and difficult to adhere to long-term. If KMgCit were shown to be effective in lowering blood pressure, it would provide a safe and convenient alternative to the DASH diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| KMgCit, KCit, KCl, Placebo | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KMgCit, KCit, Placebo, KCl | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KMgCit, KCl, KCit, Placebo | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KMgCit, KCl, Placebo, KCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KMgCit, Placebo, KCit, KCl | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KMgCit, Placebo, KCl, KCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCit, KMgCit, KCl, Placebo | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCit, KMgCit, Placebo, KCl | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCit, KCl, KMgCit, Placebo | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCit, KCl, Placebo, KMgCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCit, Placebo, KMgCit, KCl | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCit, Placebo, KCl, KMgCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCl, KMgCit, KCit, Placebo | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCl, KMgCit, Placebo, KCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCl, KCit, KMgCit, Placebo | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCl, KCit, Placebo, KMgCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCl, Placebo, KMgCit, KCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| KCl, Placebo, KCit, KMgCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| Placebo, KMgCit, KCit, KCl | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| Placebo, KMgCit, KCl, KCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| Placebo, KCit, KMgCit, KCl | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| Placebo, KCit, KCl, KMgCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| Placebo, KCl, KMgCit, KCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
| Placebo, KCl, KCit, KMgCit | Experimental | Drug: Potassium chloride powder, Drug: Potassium citrate powder, Drug: Potassium magnesium citrate powder, Drug: PlaceboParticipants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women > 21 years of age
- Any Race/Ethnicity
- Pre- or Stage I hypertension (BP >= 120/80 and <= 159/99)
Key exclusion criteria (13 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 powderAlso: KCl1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks | Drug | KCit, KCl, KMgCit, Placebo, KCit, KCl, Placebo, KMgCit, KCit, KMgCit, KCl, Placebo, KCit, KMgCit, Placebo, KCl, KCit, Placebo, KCl, KMgCit, KCit, Placebo, KMgCit, KCl, KCl, KCit, KMgCit, Placebo, KCl, KCit, Placebo, KMgCit, KCl, KMgCit, KCit, Placebo, KCl, KMgCit, Placebo, KCit, KCl, Placebo, KCit, KMgCit, KCl, Placebo, KMgCit, KCit, KMgCit, KCit, KCl, Placebo, KMgCit, KCit, Placebo, KCl, KMgCit, KCl, KCit, Placebo, KMgCit, KCl, Placebo, KCit, KMgCit, Placebo, KCit, KCl, KMgCit, Placebo, KCl, KCit, Placebo, KCit, KCl, KMgCit, Placebo, KCit, KMgCit, KCl, Placebo, KCl, KCit, KMgCit, Placebo, KCl, KMgCit, KCit, Placebo, KMgCit, KCit, KCl, Placebo, KMgCit, KCl, KCit |
| Potassium citrate powderAlso: KCit1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks | Drug | KCit, KCl, KMgCit, Placebo, KCit, KCl, Placebo, KMgCit, KCit, KMgCit, KCl, Placebo, KCit, KMgCit, Placebo, KCl, KCit, Placebo, KCl, KMgCit, KCit, Placebo, KMgCit, KCl, KCl, KCit, KMgCit, Placebo, KCl, KCit, Placebo, KMgCit, KCl, KMgCit, KCit, Placebo, KCl, KMgCit, Placebo, KCit, KCl, Placebo, KCit, KMgCit, KCl, Placebo, KMgCit, KCit, KMgCit, KCit, KCl, Placebo, KMgCit, KCit, Placebo, KCl, KMgCit, KCl, KCit, Placebo, KMgCit, KCl, Placebo, KCit, KMgCit, Placebo, KCit, KCl, KMgCit, Placebo, KCl, KCit, Placebo, KCit, KCl, KMgCit, Placebo, KCit, KMgCit, KCl, Placebo, KCl, KCit, KMgCit, Placebo, KCl, KMgCit, KCit, Placebo, KMgCit, KCit, KCl, Placebo, KMgCit, KCl, KCit |
| Potassium magnesium citrate powderAlso: KMgCit1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks | Drug | KCit, KCl, KMgCit, Placebo, KCit, KCl, Placebo, KMgCit, KCit, KMgCit, KCl, Placebo, KCit, KMgCit, Placebo, KCl, KCit, Placebo, KCl, KMgCit, KCit, Placebo, KMgCit, KCl, KCl, KCit, KMgCit, Placebo, KCl, KCit, Placebo, KMgCit, KCl, KMgCit, KCit, Placebo, KCl, KMgCit, Placebo, KCit, KCl, Placebo, KCit, KMgCit, KCl, Placebo, KMgCit, KCit, KMgCit, KCit, KCl, Placebo, KMgCit, KCit, Placebo, KCl, KMgCit, KCl, KCit, Placebo, KMgCit, KCl, Placebo, KCit, KMgCit, Placebo, KCit, KCl, KMgCit, Placebo, KCl, KCit, Placebo, KCit, KCl, KMgCit, Placebo, KCit, KMgCit, KCl, Placebo, KCl, KCit, KMgCit, Placebo, KCl, KMgCit, KCit, Placebo, KMgCit, KCit, KCl, Placebo, KMgCit, KCl, KCit |
| PlaceboAlso: Microcystalline cellulose1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks | Drug | KCit, KCl, KMgCit, Placebo, KCit, KCl, Placebo, KMgCit, KCit, KMgCit, KCl, Placebo, KCit, KMgCit, Placebo, KCl, KCit, Placebo, KCl, KMgCit, KCit, Placebo, KMgCit, KCl, KCl, KCit, KMgCit, Placebo, KCl, KCit, Placebo, KMgCit, KCl, KMgCit, KCit, Placebo, KCl, KMgCit, Placebo, KCit, KCl, Placebo, KCit, KMgCit, KCl, Placebo, KMgCit, KCit, KMgCit, KCit, KCl, Placebo, KMgCit, KCit, Placebo, KCl, KMgCit, KCl, KCit, Placebo, KMgCit, KCl, Placebo, KCit, KMgCit, Placebo, KCit, KCl, KMgCit, Placebo, KCl, KCit, Placebo, KCit, KCl, KMgCit, Placebo, KCit, KMgCit, KCl, Placebo, KCl, KCit, KMgCit, Placebo, KCl, KMgCit, KCit, Placebo, KMgCit, KCit, KCl, Placebo, KMgCit, KCl, KCit |
Primary outcome
24-hour Average Systolic Blood Pressure
Time frame: 4 weeks
This is the average systolic blood pressure over a 24 hour period.
24-hour Average Diastolic Blood Pressure
Time frame: 4 weeks
The average diastolic blood pressure over a 24 hour period.
7 secondary outcomes
Office Systolic Blood Pressure
Time frame: 4 weeks
Office Diastolic Blood Pressure
Time frame: 4 weeks
Serum C-terminal Telopeptide (CTX)
Time frame: 4 weeks
24-hour Urinary Calcium
Time frame: 4 weeks of treatment
Carotid to Femoral Pulse Wave Velocity
Time frame: 4 weeks
Central Aortic Systolic Blood Pressure
Time frame: 4 weeks
Central Aortic Diastolic Blood Pressure
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27448942Vongpatanasin W, Peri-Okonny P, Velasco A, Arbique D, Wang Z, Ravikumar P, Adams-Huet B, Moe OW, Pak CYC. Effects of Potassium Magnesium Citrate Supplementation on 24-Hour Ambulatory Blood Pressure and Oxidative Stress Marker in Prehypertensive and Hypertensive Subjects. Am J Cardiol. 2016 Sep 15;118(6):849-853. doi: 10.1016/j.amjcard.2016.06.041. Epub 2016 Jun 28.
- Individual participant dataSharing planned: No
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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.
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 2 study testing Potassium chloride powder, Potassium citrate powder and Potassium magnesium 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 3 inclusion and 13 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 28 Apr 2017. 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. 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 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?
Yes. Results are posted in the registry (first posted 28 Apr 2017). 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). The study lists 2 primary outcomes in all. 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 NCT01682837, which also lists 1 linked publication.
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 28 Apr 2017.