Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01074918
• Collaborator: (none)
• Enrollment: 0
• Locations: 2
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine.

Condition or Disease	Intervention/Treatment	Phase
Pre-hypertension; Hypertension	Drug: Potassium, Magnesium, Citrate; Drug: Potassium Chloride	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Potassium Magnesium Citrate	Drug: Potassium, Magnesium, Citrate; Potassium MAgnesium Citrate - 30 mEq potassium, 15 mEq Magnesium, 45 mEq Citrate in a powder mixture twice a day, mixed with a glass of water.
Active Comparator: Potassium Chloride	Drug: Potassium Chloride; Potassium Chloride

Outcome Measures

Primary Outcome Measures

1. Blood Pressure [8 weeks]

   We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age greater than 21 years

• BMI > 18.5 kg/m2 and < 40 kg/m2

• Prehypertension and mild hypertension: BP systolic 120-159 mmHg, diastolic 80-95 mmHg

• Must agree to limit lifestyle changes including: 1) embarking on a new exercise or weight reduction program 2) altering alcohol intake during the trial.

Exclusion Criteria:

• Taking blood pressure lowering medication

• Diabetes mellitus

• Renal disease

• Active cardiac disease

• Active liver disease

• Chronic diarrhea

• Chronic NSAID use

• Active or suspected drug use

• Uncontrolled psychiatric disease

• HIV infection

• Missed more than 20% of clinic visits in the last yr

• Prescription of diuretics for any reason

• A patient taking nutritional supplements including multivitamins that is unwilling to discontinue them,\

• Consumption of greater than 14 alcoholic beverages per week

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dallas VA Medical Center	Dallas	Texas	United States	75216
2	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orson Moe, Professor of Internal Medicine, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01074918
• Other Study ID Numbers: 012007-080
• First Posted: Feb 24, 2010
• Last Update Posted: Feb 11, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Orson Moe, Professor of Internal Medicine, University of Texas Southwestern Medical Center: Pre-hypertension; Hypertension
• Additional relevant MeSH terms: Hypertension; Prehypertension

Study Results

No Results Posted as of Feb 11, 2019