Phase 2
N=35
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01682837 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: 24-hour Average Systolic Blood Pressure — 127; 127; 126; 129 mmHg — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Potassium chloride powder (Drug); Potassium citrate powder (Drug); Potassium magnesium citrate powder (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hour Average Systolic Blood Pressure |
127; 127; 126; 129 | 0.07 |
| PRIMARY 24-hour Average Diastolic Blood Pressure |
79; 78; 78; 80 | 0.20 |
| SECONDARY Office Systolic Blood Pressure |
124; 125; 127; 129 | 0.16 |
| SECONDARY Office Diastolic Blood Pressure |
81; 81; 80; 81 | 0.70 |
| SECONDARY Serum C-terminal Telopeptide (CTX) |
0.46; 0.46; 0.45; 0.49 | 0.42 |
| SECONDARY 24-hour Urinary Calcium |
158; 148; 160; 181 | 0.10 |
| SECONDARY Carotid to Femoral Pulse Wave Velocity |
8.7; 8.8; 8.7; 8.9 | 0.64 |
| SECONDARY Central Aortic Systolic Blood Pressure |
121; 125; 123; 126 | 0.18 |
| SECONDARY Central Aortic Diastolic Blood Pressure |
77; 76; 77; 79 | 0.12 |
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.
Eligibility Criteria
Inclusion Criteria
- Men or women > 21 years of age
- Any Race/Ethnicity
- Pre- or Stage I hypertension (BP >= 120/80 and 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
Data sourced from ClinicalTrials.gov (NCT01682837). 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.