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Not yet recruiting NCT05145309

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

Phase II Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KMgCit, Placebo.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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

Interventions

  • Drug KMgCit
    Supplement that provide K, Mg, and citrate
  • Drug Placebo
    Power with identical appearance to KMgCit

Primary outcome measures

  • 24-hour systolic blood pressure (24h SBP) [Time frame: 4 weeks]
Secondary outcome measures (5)
  • central systolic blood pressure (cSBP) [Time frame: 4 weeks]
  • pulse wave velocity [Time frame: 4 weeks]
  • augmentation index [Time frame: 4 weeks]
  • FGF23 [Time frame: 4 weeks]
  • klotho [Time frame: 4 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Texas Southwestern Medical Center — Dallas

Identifiers

NCT: NCT05145309 · STU-2021-0912

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗