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Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01682837
Collaborator
(none)
35
Enrollment
1
Location
24
Arms
28.9
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Potassium chloride powder
  • Drug: Potassium citrate powder
  • Drug: Potassium magnesium citrate powder
  • Drug: Placebo
 Phase 2

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

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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
Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•
    Experimental: 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.

    Drug: 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
    Other Names:
  • KCl

    • 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
    Other Names:
  • KCit

    • 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
    Other Names:
  • KMgCit

    • Drug: Placebo
    1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
    Other Names:
  • Microcystalline cellulose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 24-hour Average Systolic Blood Pressure [4 weeks]

      This is the average systolic blood pressure over a 24 hour period.

    2. 24-hour Average Diastolic Blood Pressure [4 weeks]

      The average diastolic blood pressure over a 24 hour period.

    Secondary Outcome Measures

    1. Office Systolic Blood Pressure [4 weeks]

    2. Office Diastolic Blood Pressure [4 weeks]

    3. Serum C-terminal Telopeptide (CTX) [4 weeks]

    4. 24-hour Urinary Calcium [4 weeks of treatment]

    5. Carotid to Femoral Pulse Wave Velocity [4 weeks]

    6. Central Aortic Systolic Blood Pressure [4 weeks]

    7. Central Aortic Diastolic Blood Pressure [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hypertension Clinic - UT Southwestern Medical Center at Dallas Dallas Texas United States 75390

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center

    Investigators

    • Principal Investigator: Wanpen Vongpatanasin, MD, University of Texas Southwestern Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT01682837
    Other Study ID Numbers:
    • LiqKMgCit-1208-01
    First Posted:
    Sep 11, 2012
    Last Update Posted:
    Apr 28, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hypertension
    Potassium Citrate
    Magnesium citrate
    Citric Acid
    Sodium Citrate

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title All Study Participants
    Arm/Group Description Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.
    Period Title: Baseline
    STARTED 35
    COMPLETED 30
    NOT COMPLETED 5
    Period Title: Baseline
    STARTED 30
    Received KMgCit 8
    Received KCit 8
    Received KCl 7
    Received Placebo 7
    COMPLETED 30
    NOT COMPLETED 0
    Period Title: Baseline
    STARTED 30
    Received KMgCit 7
    Received KCit 6
    Received KCl 8
    Received Placebo 9
    COMPLETED 30
    NOT COMPLETED 0
    Period Title: Baseline
    STARTED 30
    Received KMgCit 9
    Received KCit 7
    Received KCl 7
    Received Placebo 7
    COMPLETED 30
    NOT COMPLETED 0
    Period Title: Baseline
    STARTED 30
    Received KMgCit 6
    Received KCit 9
    Received KCl 8
    Received Placebo 7
    COMPLETED 30
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title All Study Participants
    Arm/Group Description Participants received the following study drug in random order: Potassium Magnesium Citrate powder, Potassium 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.
    Overall Participants 30
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54
    (12)
    Sex: Female, Male (Count of Participants)
    Female
    16
    53.3%
    Male
    14
    46.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    13.3%
    Not Hispanic or Latino
    26
    86.7%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    12
    40%
    White
    18
    60%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    30
    100%
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    31
    (5)
    Office Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    125
    (11)
    Office Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    81
    (8)
    Office Heart Rate (beats per minute) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [beats per minute]
    72
    (11)
    24-hr Systolic Blood Pressure Average (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    126
    (10)
    24-hr Diastolic Blood Pressure Average (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    79
    (10)
    24-hr Heart Rate Average (beats per minute) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [beats per minute]
    76
    (11)
    24-hr Daytime Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    129
    (10)
    24-hr Daytime Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    81
    (11)
    24-hr Daytime Heart Rate (beats per minute) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [beats per minute]
    77
    (11)
    24-hr Nighttime Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    117
    (12)
    24-hr Nighttime Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    71
    (10)
    24-hr Nighttime Heart Rate (beats per minute) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [beats per minute]
    70
    (11)
    Serum Calcium (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    9.5
    (0.5)
    Serum Phosphorus (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    3.6
    (0.1)
    Serum Magnesium (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    2.2
    (0.3)
    Serum Sodium (meq/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [meq/L]
    139
    (2)
    Serum Potassium (meq/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [meq/L]
    4.2
    (0.3)
    Serum Chloride (meq/L) (meq/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [meq/L]
    105
    (2)
    Serum Bicarbonate (meq/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [meq/L]
    23
    (2)
    Serum Urea Nitrogen (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    13.7
    (3.5)
    Serum Creatinine (mg/dl) (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    0.9
    (0.2)
    Serum Albumin (g/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [g/dl]
    4.2
    (0.6)
    Serum Parathyroid Hormone (pg/ml) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [pg/ml]
    59
    (31)
    Serum 1,25-Dihydroxyvitamin D (pg/ml) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [pg/ml]
    73
    (34)

    Outcome Measures

    1. Primary Outcome
    Title 24-hour Average Systolic Blood Pressure
    Description This is the average systolic blood pressure over a 24 hour period.
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the study completed all 4 phases.
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [mmHg]
    127
    (11)
    127
    (10)
    126
    (9)
    129
    (13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments
    Method Mixed Models Analysis
    Comments
    2. Primary Outcome
    Title 24-hour Average Diastolic Blood Pressure
    Description The average diastolic blood pressure over a 24 hour period.
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [mmHg]
    79
    (10)
    78
    (9)
    78
    (9)
    80
    (11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.20
    Comments
    Method Mixed Models Analysis
    Comments
    3. Secondary Outcome
    Title Office Systolic Blood Pressure
    Description
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [mmHg]
    124
    (11)
    125
    (13)
    127
    (11)
    129
    (12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments
    Method Mixed Models Analysis
    Comments
    4. Secondary Outcome
    Title Office Diastolic Blood Pressure
    Description
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [mmHg]
    81
    (9)
    81
    (8)
    80
    (9)
    81
    (9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.70
    Comments
    Method Mixed Models Analysis
    Comments
    5. Secondary Outcome
    Title Serum C-terminal Telopeptide (CTX)
    Description
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [ng/ml]
    0.46
    (0.28)
    0.46
    (0.28)
    0.45
    (0.25)
    0.49
    (0.33)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.42
    Comments
    Method Mixed Models Analysis
    Comments
    6. Secondary Outcome
    Title 24-hour Urinary Calcium
    Description
    Time Frame 4 weeks of treatment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [mg/day]
    158
    (94)
    148
    (78)
    160
    (92)
    181
    (101)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.10
    Comments
    Method Mixed Models Analysis
    Comments
    7. Secondary Outcome
    Title Carotid to Femoral Pulse Wave Velocity
    Description
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [m/s]
    8.7
    (1.7)
    8.8
    (1.6)
    8.7
    (1.5)
    8.9
    (1.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.64
    Comments
    Method Mixed Models Analysis
    Comments
    8. Secondary Outcome
    Title Central Aortic Systolic Blood Pressure
    Description
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [mmHg]
    121
    (11)
    125
    (16)
    123
    (13)
    126
    (14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments
    Method Mixed Models Analysis
    Comments
    9. Secondary Outcome
    Title Central Aortic Diastolic Blood Pressure
    Description
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    Measure Participants 30 30 30 30
    Mean (Standard Deviation) [mmHg]
    77
    (7)
    76
    (7)
    77
    (9)
    79
    (8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Potassium Magnesium Citrate Powder Phase, Potassium Citrate Powder Phase, Potassium Chloride Powder Phase, Placebo Phase
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.12
    Comments
    Method Mixed Models Analysis
    Comments

    Adverse Events

    Time Frame Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
    Adverse Event Reporting Description Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
    Arm/Group Title Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Arm/Group Description Participants undergoing the Potassium Magnesium Citrate powder phase of the study. Participants undergoing the Potassium Citrate powder phase of the study. Participants undergoing the Potassium Chloride powder phase of the study. Participants undergoing the Placebo phase of the study.
    All Cause Mortality
    Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/30 (0%) 0/30 (0%) 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    Potassium Magnesium Citrate Powder Phase Potassium Citrate Powder Phase Potassium Chloride Powder Phase Placebo Phase
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/30 (16.7%) 5/30 (16.7%) 16/30 (53.3%) 4/30 (13.3%)
    Gastrointestinal disorders
    Nausea 2/30 (6.7%) 2 1/30 (3.3%) 1 1/30 (3.3%) 1 1/30 (3.3%) 1
    Belching 0/30 (0%) 0 1/30 (3.3%) 1 2/30 (6.7%) 3 0/30 (0%) 0
    Diarrhea 1/30 (3.3%) 1 0/30 (0%) 0 1/30 (3.3%) 1 1/30 (3.3%) 1
    Loose Bowel Movement 0/30 (0%) 0 0/30 (0%) 0 4/30 (13.3%) 6 0/30 (0%) 0
    Pain and/or Cramps 0/30 (0%) 0 1/30 (3.3%) 1 1/30 (3.3%) 2 1/30 (3.3%) 1
    Dyspepsia 0/30 (0%) 0 0/30 (0%) 0 0/30 (0%) 0 1/30 (3.3%) 1
    Dysgeusia 2/30 (6.7%) 3 2/30 (6.7%) 3 12/30 (40%) 18 2/30 (6.7%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title John Poindexter
    Organization UT Southwestern Medical Center at Dallas
    Phone 2146486857
    Email john.poindexter@utsouthwestern.edu
    Responsible Party:
    University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT01682837
    Other Study ID Numbers:
    • LiqKMgCit-1208-01
    First Posted:
    Sep 11, 2012
    Last Update Posted:
    Apr 28, 2017
    Last Verified:
    Mar 1, 2017