Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75390
        • Hypertension Clinic - UT Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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.
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour Average Systolic Blood Pressure
Time Frame: 4 weeks
This is the average systolic blood pressure over a 24 hour period.
4 weeks
24-hour Average Diastolic Blood Pressure
Time Frame: 4 weeks
The average diastolic blood pressure over a 24 hour period.
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Office Systolic Blood Pressure
Time Frame: 4 weeks
4 weeks
Office Diastolic Blood Pressure
Time Frame: 4 weeks
4 weeks
Serum C-terminal Telopeptide (CTX)
Time Frame: 4 weeks
4 weeks
24-hour Urinary Calcium
Time Frame: 4 weeks of treatment
4 weeks of treatment
Carotid to Femoral Pulse Wave Velocity
Time Frame: 4 weeks
4 weeks
Central Aortic Systolic Blood Pressure
Time Frame: 4 weeks
4 weeks
Central Aortic Diastolic Blood Pressure
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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