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NCT05145309 | Not yet recruiting | Hypertension


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

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

Wan sprayed VO about your GPA during those four years

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, particularly in African Americans (AA). Key components of such a diet are potassium, magnesium, and alkali, each of which has been implicated in lowering blood pressure. In the original IND 116,208, the investigators explored whether potassium-magnesium citrate (KMgCit) as a powder pharmaceutical formulation (dissolved in water before ingestion) could serve as a surrogate for the DASH diet and would lower blood pressure among patients with pre- or Stage I hypertension. Unfortunately, previous studies did not include adequate number of African American patients.

Condition or disease

Hypertension

Intervention/treatment

KMgCit

Placebo

Phase

Phase 2

Detailed 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}}

Study Type : Interventional
Estimated Enrollment : 45 participants
Masking : Double
Masking Description : The study supplement will be dispensed in a blinded manner.
Primary Purpose : Treatment
Official Title : Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans
Actual Study Start Date : December 15, 2024
Estimated Primary Completion Date : December 1, 2029
Estimated Study Completion Date : December 1, 2030
Arm Intervention/treatment

Experimental: Potassium Magnesium Citrate (KMgCit) first then Placebo

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

Drug: KMgCit

Drug: Placebo

Experimental: Placebo first then KMgCit

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

Drug: KMgCit

Drug: Placebo

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: All
Accepts 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.

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

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

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Locations


Not yet recruiting

United States, Texas

University of Texas Southwestern Medical Center

dallas, Texas, United States, 75390

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