Clinical trial
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Name
STU 072012-001
Description
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.
Trial arms
Trial start
2012-09-01
Estimated PCD
2015-01-01
Trial end
2015-01-01
Status
Completed
Phase
Early phase I
Treatment
Potassium chloride powder
Arms:
Potassium chloride arm
Potassium magnesium Citrate (KMgCit)
Arms:
Potassium magnesium Citrate (KMgCit) arm
Potassium citrate powder
Arms:
Potassium citrate arm
Other names:
Urocit®-K powder
Placebo
Arms:
Placebo
Size
30
Primary endpoint
24-hour Average Systolic Blood Pressure
4 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-10-16
1 organization
3 products
1 drug
1 indication
Organization
University of Texas Southwestern Medical CenterProduct
Potassium ChlorideIndication
HypertensionProduct
Potassium Magnesium CitrateProduct
Potassium citrateDrug
Varlilumab