Clinical trial NCT01682837: Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Official title: Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.

Detailed description: In this protocol, the investigators want to explore whether KMgCit taken during a customary dietary setting, might serve as a "surrogate" for the Dietary Approaches to Stop Hypertension (DASH) diet to lower blood pressure. This study has obvious biomedical importance. Lifestyle modifications are often recommended for pre- or Stage I hypertension. The DASH diet is such a modification that has been shown to be effective. However, this diet is costly and difficult to adhere to long-term. If KMgCit were shown to be effective in lowering blood pressure, it would provide a safe and convenient alternative to the DASH diet.

Eligibility criteria: Inclusion Criteria:

* Men or women \> 21 years of age
* Any Race/Ethnicity
* Pre- or Stage I hypertension (BP \>= 120/80 and \<= 159/99)

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 meq/L for patients on angiotension-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), serum K \> 5.0 meq/L for patient not on ACE inhibitors or ARBs)
* Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase (ALT) 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

Primary outcomes:
measure: 24-hour Average Systolic Blood Pressure
timeFrame: 4 weeks
measure: 24-hour Average Diastolic Blood Pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: Office Systolic Blood Pressure
timeFrame: 4 weeks
measure: Office Diastolic Blood Pressure
timeFrame: 4 weeks
measure: Serum C-terminal Telopeptide (CTX)
timeFrame: 4 weeks
measure: 24-hour Urinary Calcium
timeFrame: 4 weeks of treatment
measure: Carotid to Femoral Pulse Wave Velocity
timeFrame: 4 weeks
measure: Central Aortic Systolic Blood Pressure
timeFrame: 4 weeks
measure: Central Aortic Diastolic Blood Pressure
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Hypertension Clinic - UT Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Wanpen Vongpatanasin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vongpatanasin W, Peri-Okonny P, Velasco A, Arbique D, Wang Z, Ravikumar P, Adams-Huet B, Moe OW, Pak CYC. Effects of Potassium Magnesium Citrate Supplementation on 24-Hour Ambulatory Blood Pressure and Oxidative Stress Marker in Prehypertensive and Hypertensive Subjects. Am J Cardiol. 2016 Sep 15;118(6):849-853. doi: 10.1016/j.amjcard.2016.06.041. Epub 2016 Jun 28.