Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

NCT ID: NCT01682837

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-03-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KMgCit, KCit, KCl, Placebo

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KMgCit, KCit, Placebo, KCl

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KMgCit, KCl, KCit, Placebo

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KMgCit, KCl, Placebo, KCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KMgCit, Placebo, KCit, KCl

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KMgCit, Placebo, KCl, KCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCit, KMgCit, KCl, Placebo

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCit, KMgCit, Placebo, KCl

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCit, KCl, KMgCit, Placebo

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCit, KCl, Placebo, KMgCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCit, Placebo, KMgCit, KCl

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCit, Placebo, KCl, KMgCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCl, KMgCit, KCit, Placebo

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCl, KMgCit, Placebo, KCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCl, KCit, KMgCit, Placebo

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCl, KCit, Placebo, KMgCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCl, Placebo, KMgCit, KCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

KCl, Placebo, KCit, KMgCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Placebo, KMgCit, KCit, KCl

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Placebo, KMgCit, KCl, KCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Placebo, KCit, KMgCit, KCl

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Placebo, KCit, KCl, KMgCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Placebo, KCl, KMgCit, KCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Placebo, KCl, KCit, KMgCit

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.

Group Type: EXPERIMENTAL

Potassium chloride powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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 powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Interventions

Potassium chloride powder

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

Intervention Type: DRUG

Potassium citrate powder

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

Intervention Type: DRUG

Potassium magnesium citrate powder

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

Intervention Type: DRUG

Placebo

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention Type: DRUG

Other Intervention Names

KCl; KCit; KMgCit; Microcystalline cellulose

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wanpen Vongpatanasin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Hypertension Clinic - UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27448942 (View on PubMed)

Other Identifiers

LiqKMgCit-1208-01

Identifier Type: -

Identifier Source: org_study_id