Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02653560
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 4
• Duration (Months): 28
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension. Key components of such a diet are potassium, magnesium and alkali, each of which has been implicated in lowering blood pressure. Whether a liquid formulation of potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is unknown.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Potassium chloride powder; Drug: Potassium magnesium Citrate (KMgCit); Drug: Potassium citrate powder; Drug: Placebo	Phase 4

Detailed Description

The DASH diet is rich in potassium and magnesium. It is also high in alkali content, since the anions are provided mostly by citrate rather than chloride. Considerable data are already available in the literature invoking a protective role on hypertension of potassium, magnesium and alkali.

In this protocol, the investigators want to test the hypothesis that liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation could serve as a surrogate for the DASH diet, and would lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.

Each subject will participate in all four phases, chosen in random order. The four phases will be: Placebo Phase (microcrystalline cellulose in water), Potassium Chloride Phase (potassium chloride powder in water), Potassium Citrate Phase (potassium citrate powder in water), KMgCit Phase (KMgCit powder in water) During each phase, subjects will receive one of the test drugs for 4 weeks, followed by at least 1 week of withdrawal. Change in 24 hr BP, office BP will be measured at baseline and after each phase. Central aortic blood pressure and carotid-femoral pulse wave velocity, -terminal-telopeptide (CTX), 24 hr urine electrolytes will be measured at 4 weeks in each phase.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Potassium magnesium Citrate (KMgCit) arm 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	Drug: Potassium magnesium Citrate (KMgCit)
Experimental: Potassium citrate arm 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.	Drug: Potassium citrate powder; Other Names: Urocit®-K powder
Experimental: Potassium chloride arm 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	Drug: Potassium chloride powder
Placebo Comparator: Placebo 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.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm

• Age > 21 years of age

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 mmol/L for patients on Angiotensin converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARB), serum K > 5.0 for patient not on ACE inhibitors or ARBs)

• Liver function test 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

• History of substance abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas 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, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wanpen Vongpatanasin, Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02653560
• Other Study ID Numbers: STU 072012-001
• First Posted: Jan 12, 2016
• Last Update Posted: Jul 28, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Wanpen Vongpatanasin, Professor, University of Texas Southwestern Medical Center: Potassium; Magnesium; Citrate; DASH
• Additional relevant MeSH terms: Hypertension; Potassium Citrate; Magnesium citrate; Citric Acid; Sodium Citrate

Study Results

Participant Flow

Arm/Group Title	Potassium Magnesium Citrate (KMgCit) Arm	Potassium Citrate Arm	Potassium Chloride Arm	Placebo
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: KMgCit Phase
STARTED	0	30	0	0
COMPLETED	0	30	0	0
NOT COMPLETED	0	0	0	0
Period Title: KMgCit Phase
STARTED	0	0	30	0
COMPLETED	0	0	30	0
NOT COMPLETED	0	0	0	0
Period Title: KMgCit Phase
STARTED	0	0	0	30
COMPLETED	0	0	0	30
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
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 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%

Outcome Measures

1. Primary Outcome

Title	24-hour Average Systolic Blood Pressure
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Potassium Magnesium Citrate (KMgCit) Arm	Potassium Citrate Arm	Potassium Chloride Arm	Placebo
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
Measure Participants	30	30	30	30
Mean (Standard Deviation) [mmHg]	127 (11)	127 (10)	126 (9)	129 (13)

Adverse Events

Arm/Group Title	Potassium Magnesium Citrate (KMgCit) Arm		Potassium Citrate Arm		Potassium Chloride Arm		Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Potassium Magnesium Citrate (KMgCit) Arm		Potassium Citrate Arm		Potassium Chloride Arm		Placebo
	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 (KMgCit) Arm		Potassium Citrate Arm		Potassium Chloride Arm		Placebo
	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%)

Limitations/Caveats

[Not Specified]

More Information

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.