Phase 4 N=30 Randomized Double-blind Treatment

Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT02653560 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: 24-hour Average Systolic Blood Pressure — 127; 127; 126; 129 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Potassium chloride powder (Drug); Potassium magnesium Citrate (KMgCit) (Drug); Potassium citrate powder (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 24-hour Average Systolic Blood Pressure	127; 127; 126; 129	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02653560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.