Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Potassium citrate powder; Drug: Potassium chloride powder; Drug: Potassium magnesium citrate powder

Study type: Interventional

Funder types: Other

Identifiers

NCT01682837

LiqKMgCit-1208-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 24 patient groups

KMgCit, KCit, KCl, Placebo

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KMgCit, KCit, Placebo, KCl

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KMgCit, KCl, KCit, Placebo

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KMgCit, KCl, Placebo, KCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KMgCit, Placebo, KCit, KCl

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KMgCit, Placebo, KCl, KCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCit, KMgCit, KCl, Placebo

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCit, KMgCit, Placebo, KCl

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCit, KCl, KMgCit, Placebo

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCit, KCl, Placebo, KMgCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCit, Placebo, KMgCit, KCl

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCit, Placebo, KCl, KMgCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCl, KMgCit, KCit, Placebo

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCl, KMgCit, Placebo, KCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCl, KCit, KMgCit, Placebo

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCl, KCit, Placebo, KMgCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCl, Placebo, KMgCit, KCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

KCl, Placebo, KCit, KMgCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

Placebo, KMgCit, KCit, KCl

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

Placebo, KMgCit, KCl, KCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

Placebo, KCit, KMgCit, KCl

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

Placebo, KCit, KCl, KMgCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

Placebo, KCl, KMgCit, KCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo

Placebo, KCl, KCit, KMgCit

Experimental group

Description:

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.

Treatment:

Drug: Potassium magnesium citrate powder

Drug: Potassium citrate powder

Drug: Potassium chloride powder

Drug: Placebo