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

NCT01074918 | Withdrawn Phase 1 DMC

• 1 other identifier: 012007-080
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Pre-hypertension; Hypertension

Keywords

Pre-hypertension; Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

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

  8 weeks

Study Arms (2)

Potassium Magnesium Citrate

EXPERIMENTAL

Drug: Potassium, Magnesium, Citrate

Potassium Chloride

ACTIVE COMPARATOR

Drug: Potassium Chloride

Interventions

Potassium, Magnesium, Citrate DRUG

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.

Potassium Magnesium Citrate

Potassium Chloride DRUG

Potassium Chloride

Potassium Chloride

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Interventions

potassium-magnesium citrate; Potassium Chloride

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Potassium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 24, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

US (2)