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Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

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ClinicalTrials.gov Identifier: NCT02653560
Recruitment Status : Completed
First Posted : January 12, 2016
Results First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Wanpen Vongpatanasin, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Potassium chloride powder
Drug: Potassium magnesium Citrate (KMgCit)
Drug: Potassium citrate powder
Drug: Placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Potassium Magnesium Citrate (KMgCit) Arm Potassium Citrate Arm Potassium Chloride Arm Placebo
Hide Arm/Group Description

Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks

Potassium magnesium Citrate (KMgCit)

A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.

Potassium citrate powder

Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks

Potassium chloride powder

Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.

Placebo

Period Title: KMgCit Phase
Started 30 0 0 0
Completed 30 0 0 0
Not Completed 0 0 0 0
Period Title: K Citrate Phase
Started 0 30 0 0
Completed 0 30 0 0
Not Completed 0 0 0 0
Period Title: KCl Phase
Started 0 0 30 0
Completed 0 0 30 0
Not Completed 0 0 0 0
Period Title: Placebo Phase
Started 0 0 0 30
Completed 0 0 0 30
Not Completed 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Participants took Potassium magnesium Citrate (KMgCit), potassium citrate (KCit), potassium chloride (KCl) and placebo each for 4 weeks in a randomized crossover design.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Randomized cross over design so total number of subjects = 30
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
54  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
16
  53.3%
Male
14
  46.7%
1.Primary Outcome
Title 24-hour Average Systolic Blood Pressure
Hide Description Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Potassium Magnesium Citrate (KMgCit) Arm Potassium Citrate Arm Potassium Chloride Arm Placebo
Hide Arm/Group Description:

Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks

Potassium magnesium Citrate (KMgCit)

A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.

Potassium citrate powder

Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks

Potassium chloride powder

Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.

Placebo

Overall Number of Participants Analyzed 30 30 30 30
Mean (Standard Deviation)
Unit of Measure: mmHg
127  (11) 127  (10) 126  (9) 129  (13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Potassium Magnesium Citrate (KMgCit) Arm Potassium Citrate Arm Potassium Chloride Arm Placebo
Hide Arm/Group Description

Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks

Potassium magnesium Citrate (KMgCit)

A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.

Potassium citrate powder

Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks

Potassium chloride powder

Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.

Placebo

All-Cause Mortality
Potassium Magnesium Citrate (KMgCit) Arm Potassium Citrate Arm Potassium Chloride Arm Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Potassium Magnesium Citrate (KMgCit) Arm Potassium Citrate Arm Potassium Chloride Arm Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Potassium Magnesium Citrate (KMgCit) Arm Potassium Citrate Arm Potassium Chloride Arm Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT 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
Layout table for Results Point of Contact information
Name/Title: Dr Wanpen Vongpatanasin
Organization: UT Southwestern Medical Center
Phone: 2146489078
EMail: wanpen.vongpatanasin@utsouthwestern.edu
Publications of Results:
Layout table for additonal information
Responsible Party: Wanpen Vongpatanasin, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02653560    
Other Study ID Numbers: STU 072012-001
First Submitted: January 8, 2016
First Posted: January 12, 2016
Results First Submitted: May 10, 2016
Results First Posted: July 28, 2016
Last Update Posted: July 28, 2016