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Hypertension | Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

Hypertension research study

What is the primary objective of 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.

Who is eligible to participate?

Inclusion Criteria: - Men or women > 21 years of age - Any Race/Ethnicity - Pre- or Stage I hypertension (BP >= 120/80 and <= 159/99) Exclusion Criteria: - 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 - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypertension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Potassium chloride powder1 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:Potassium citrate powder1 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:Potassium magnesium citrate powder1 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:Placebo1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

KMgCit, KCit, KCl, 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, KClParticipants 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, 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, KCitParticipants 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, KClParticipants 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, KCitParticipants 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, 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, KClParticipants 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, 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, KMgCitParticipants 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, KClParticipants 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, KMgCitParticipants 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, 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, KCitParticipants 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, 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, KMgCitParticipants 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, KCitParticipants 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, KMgCitParticipants 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, KClParticipants 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, KCitParticipants 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, KClParticipants 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, KMgCitParticipants 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, KCitParticipants 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, KMgCitParticipants 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.

Study Status

Completed

Start Date: October 2012

Completed Date: March 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: 24-hour Average Systolic Blood Pressure

Secondary Outcome: Office Systolic Blood Pressure

Study sponsors, principal investigator, and references

Principal Investigator: Wanpen Vongpatanasin, MD

Lead Sponsor: University of Texas Southwestern Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01682837

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.

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