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Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans

Studies

Study First Submitted Date 2021-11-10
Study First Posted Date 2021-12-06
Last Update Posted Date 2023-04-26
Start Month Year March 15, 2024
Primary Completion Month Year March 1, 2029
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-04-26

Detailed Descriptions

Sequence: 20614814
Description This is a double blind, randomized crossover trial comprising two phases: Placebo Phase (microcrystalline cellulose in water) and KMgCit Phase (KMgCit powder in water) to investigate the use of KMgCit in lowering blood pressure and reducing arterial stiffness. One half of the subjects will undergo the Placebo phase first followed by the KMgCit phase. The other half will undergo the KMgCit phase first followed by the Placebo phase. Each phase is 4 weeks in duration with at least 1 week washout between phases. Forty-five African American patients of either sex with pre- or Stage I hypertension, with systolic blood pressure of 120-139 mm or diastolic of < 90 mmHg according the 2017 ACC/AHA high BP guideline, will be recruited into the trial, with the expectation that 36 patients would complete both phases of the trial (assuming 20% dropout). They may be AA adult men or women (> 21 years of age). They may be on ACE inhibitor or ARB, but not on spironolactone or diuretic. Excluded will be patients with diabetes mellitus, renal impairment, heart disease, chronic NSAID use, gastrointestinal reflux disease requiring treatment with acid reducing agent of antacid more than once a week, esophageal-gastric ulcer, chronic diarrhea, hyperkalemia, abnormal liver function test, subjects who require potassium supplementation on a regular basis for any reason, pregnancy, history of major depression, bipolar disorder or schizophrenia, and history of substance abuse

Facilities

Sequence: 199008890
Name University of Texas Southwestern Medical Center
City Dallas
State Texas
Zip 75390
Country United States

Facility Contacts

Sequence: 27985407
Facility Id 199008890
Contact Type primary
Name Danielle Pittman, RN
Email Danielle.Pittman@UTSouthwestern.edu
Phone 214-648-5940

Facility Investigators

Sequence: 18256846
Facility Id 199008890
Role Principal Investigator
Name Wanpen Vongpatanasin, MD

Browse Interventions

Sequence: 95518346 Sequence: 95518347 Sequence: 95518348
Mesh Term Magnesium citrate Mesh Term Cathartics Mesh Term Gastrointestinal Agents
Downcase Mesh Term magnesium citrate Downcase Mesh Term cathartics Downcase Mesh Term gastrointestinal agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51897924
Name Hypertension
Downcase Name hypertension

Id Information

Sequence: 39944231
Id Source org_study_id
Id Value STU-2021-0912

Countries

Sequence: 42336488
Name United States
Removed False

Design Groups

Sequence: 55308984 Sequence: 55308985
Group Type Experimental Group Type Experimental
Title Potassium Magnesium Citrate (KMgCit) first then Placebo Title Placebo first then KMgCit
Description Patients will be asked to take KMgCit ( Sterling Pharmaceutical Services) first for 4 weeks. 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. Then, subjects will be asked to take Placebo packaged in an identical sachet by dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks Description Patients will be asked to take Placebo packaged in an identical sachet by dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks. Then, subjects will be asked to take KMgCit (Sterling Pharmaceutical Services, Dupo, IL) after dissolving in 250 ml water and drink it with breakfast and again with dinner for 4 weeks

Interventions

Sequence: 52213830 Sequence: 52213831
Intervention Type Drug Intervention Type Drug
Name KMgCit Name Placebo
Description Supplement that provide K, Mg, and citrate Description Power with identical appearance to KMgCit

Design Outcomes

Sequence: 176448735 Sequence: 176448736 Sequence: 176448738 Sequence: 176448739 Sequence: 176448740 Sequence: 176448737
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure 24-hour systolic blood pressure (24h SBP) Measure central systolic blood pressure (cSBP) Measure augmentation index Measure FGF23 Measure klotho Measure pulse wave velocity
Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks
Description 24-hour blood pressures will be recorded using the Spacelab ambulatory oscillometric blood pressure monitor (ABPM) (Spacelabs Medical, Issaquah, WA). Recordings will be made every 20 minutes during the day and every 30 minutes at night. Average data will be calculated for each patient and reported as mmHg. Description Arterial tonometry and simultaneous ECG will be obtained from the brachial, radial, femoral and carotid arteries noninvasively on the skin using a custom pulse transducer device manufactured by Cardiovascular Engineering, Inc. Carotid systolic BP will be used as central systolic blood pressure. The body surface distances from the suprasternal notch to the brachial (SSN-B), radial (SSN-R), femoral (SSN-F) to calculate carotid to femoral pulse wave velocity. Data will be reported as mmHg. Description Arterial tonometry and simultaneous ECG will be obtained from the brachial, radial, femoral and carotid arteries noninvasively on the skin, using a custom pulse transducer device manufactured by Cardiovascular Engineering, Inc. Carotid systolic BP will be used as central systolic blood pressure. The computer program will analyze carotid waveform to calculate augmentation index. data will be reported as %. Description Blood samples will be obtained after 4 weeks of study intervention for measurement of FGF23 concentration, a hormone involved in bone metabolism Description Blood samples will be obtained after 4 weeks of study intervention for measurement of klotho concentration, a hormone involved in bone metabolism Description Arterial tonometry and simultaneous ECG will be obtained from the brachial, radial, femoral and carotid arteries noninvasively on the skin, using a custom pulse transducer device manufactured by Cardiovascular Engineering, Inc. Carotid systolic BP will be used as central systolic blood pressure. The body surface distances from the suprasternal notch to the brachial (SSN-B), radial (SSN-R), femoral (SSN-F) to calculate carotid to femoral pulse wave velocity. Data will be reported as meter/second.

Browse Conditions

Sequence: 192388034 Sequence: 192388035 Sequence: 192388036
Mesh Term Hypertension Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases
Downcase Mesh Term hypertension Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48062565
Agency Class OTHER
Lead Or Collaborator lead
Name University of Texas Southwestern Medical Center

Design Group Interventions

Sequence: 67805372 Sequence: 67805373 Sequence: 67805374 Sequence: 67805375
Design Group Id 55308985 Design Group Id 55308984 Design Group Id 55308985 Design Group Id 55308984
Intervention Id 52213830 Intervention Id 52213830 Intervention Id 52213831 Intervention Id 52213831

Eligibilities

Sequence: 30603404
Gender All
Minimum Age 21 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria: -African American patients with pre- or Stage I hypertension, with systolic blood pressure of 120-139 mm or diastolic BP of < 90 mmHg. 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, including spironolactone Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agent or antacid more than once a week, Esophageal-gastric ulcer, Chronic diarrhea, Hyperkalemia (serum K > 5.0 mmol/L), Abnormal liver function test (AST or ALT above upper limit of normal range), Subjects who require any potassium supplement on a regular basis for any reason, Pregnancy, History of major depression, bipolar disorder, or schizophrenia, and History of substance abuse.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253915916
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 21
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30350766
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Masking Description The study supplement will be dispensed in a blinded manner.
Subject Masked True
Investigator Masked True

Intervention Other Names

Sequence: 26541213
Intervention Id 52213830
Name Potassium Magnesium Citrate

Provided Documents

Sequence: 2570768
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2021-09-15
Url https://ClinicalTrials.gov/ProvidedDocs/09/NCT05145309/Prot_SAP_000.pdf

Responsible Parties

Sequence: 28724131
Responsible Party Type Principal Investigator
Name Wanpen Vongpatanasin
Title Professor of Medicine
Affiliation University of Texas Southwestern Medical Center