Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

NCT01682837 | Completed Phase 2 Results

• 1 other identifier: LiqKMgCit-1208-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 24-hour Average Systolic Blood Pressure

  This is the average systolic blood pressure over a 24 hour period.

  4 weeks

• 24-hour Average Diastolic Blood Pressure

  The average diastolic blood pressure over a 24 hour period.

  4 weeks

Secondary Outcomes (7)

• Office Systolic Blood Pressure

  4 weeks

• Office Diastolic Blood Pressure

  4 weeks

• Serum C-terminal Telopeptide (CTX)

  4 weeks

• 24-hour Urinary Calcium

  4 weeks of treatment

• Carotid to Femoral Pulse Wave Velocity

  4 weeks

Study Arms (24)

KMgCit, KCit, KCl, Placebo

EXPERIMENTAL

Participants who received study drug in the order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KMgCit, KCit, Placebo, KCl

EXPERIMENTAL

Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KMgCit, KCl, KCit, Placebo

EXPERIMENTAL

Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KMgCit, KCl, Placebo, KCit

EXPERIMENTAL

Participants who received study drug in the order: Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KMgCit, Placebo, KCit, KCl

EXPERIMENTAL

Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KMgCit, Placebo, KCl, KCit

EXPERIMENTAL

Participants who received study drug in the order: Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCit, KMgCit, KCl, Placebo

EXPERIMENTAL

Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCit, KMgCit, Placebo, KCl

EXPERIMENTAL

Participants who received study drug in the order: Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCit, KCl, KMgCit, Placebo

EXPERIMENTAL

Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCit, KCl, Placebo, KMgCit

EXPERIMENTAL

Participants who received study drug in the order: Potassium Citrate powder, Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCit, Placebo, KMgCit, KCl

EXPERIMENTAL

Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCit, Placebo, KCl, KMgCit

EXPERIMENTAL

Participants who received study drug in the order: Potassium Citrate powder, Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCl, KMgCit, KCit, Placebo

EXPERIMENTAL

Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCl, KMgCit, Placebo, KCit

EXPERIMENTAL

Participants who received study drug in the order: Potassium Chloride powder, Potassium Magnesium Citrate powder, Placebo, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCl, KCit, KMgCit, Placebo

EXPERIMENTAL

Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCl, KCit, Placebo, KMgCit

EXPERIMENTAL

Participants who received study drug in the order: Potassium Chloride powder, Potassium Citrate powder, Placebo, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCl, Placebo, KMgCit, KCit

EXPERIMENTAL

Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

KCl, Placebo, KCit, KMgCit

EXPERIMENTAL

Participants who received study drug in the order: Potassium Chloride powder, Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

Placebo, KMgCit, KCit, KCl

EXPERIMENTAL

Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

Placebo, KMgCit, KCl, KCit

EXPERIMENTAL

Participants who received study drug in the order: Placebo, Potassium Magnesium Citrate powder, Potassium Chloride powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

Placebo, KCit, KMgCit, KCl

EXPERIMENTAL

Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Magnesium Citrate powder, Potassium Chloride powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

Placebo, KCit, KCl, KMgCit

EXPERIMENTAL

Participants who received study drug in the order: Placebo, Potassium Citrate powder, Potassium Chloride powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

Placebo, KCl, KMgCit, KCit

EXPERIMENTAL

Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Magnesium Citrate powder, Potassium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

Placebo, KCl, KCit, KMgCit

EXPERIMENTAL

Participants who received study drug in the order: Placebo, Potassium Chloride powder, Potassium Citrate powder, Potassium Magnesium Citrate powder. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.

Drug: Potassium chloride powder; Drug: Potassium citrate powder; Drug: Potassium magnesium citrate powder; Drug: Placebo

Interventions

Potassium chloride powder DRUG

1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks

Also known as: KCl

KCit, KCl, KMgCit, Placebo; KCit, KCl, Placebo, KMgCit; KCit, KMgCit, KCl, Placebo; KCit, KMgCit, Placebo, KCl; KCit, Placebo, KCl, KMgCit; KCit, Placebo, KMgCit, KCl; KCl, KCit, KMgCit, Placebo; KCl, KCit, Placebo, KMgCit; KCl, KMgCit, KCit, Placebo; KCl, KMgCit, Placebo, KCit; KCl, Placebo, KCit, KMgCit; KCl, Placebo, KMgCit, KCit; KMgCit, KCit, KCl, Placebo; KMgCit, KCit, Placebo, KCl; KMgCit, KCl, KCit, Placebo; KMgCit, KCl, Placebo, KCit; KMgCit, Placebo, KCit, KCl; KMgCit, Placebo, KCl, KCit; Placebo, KCit, KCl, KMgCit; Placebo, KCit, KMgCit, KCl; Placebo, KCl, KCit, KMgCit; Placebo, KCl, KMgCit, KCit; Placebo, KMgCit, KCit, KCl; Placebo, KMgCit, KCl, KCit

Potassium citrate powder DRUG

1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Also known as: KCit

KCit, KCl, KMgCit, Placebo; KCit, KCl, Placebo, KMgCit; KCit, KMgCit, KCl, Placebo; KCit, KMgCit, Placebo, KCl; KCit, Placebo, KCl, KMgCit; KCit, Placebo, KMgCit, KCl; KCl, KCit, KMgCit, Placebo; KCl, KCit, Placebo, KMgCit; KCl, KMgCit, KCit, Placebo; KCl, KMgCit, Placebo, KCit; KCl, Placebo, KCit, KMgCit; KCl, Placebo, KMgCit, KCit; KMgCit, KCit, KCl, Placebo; KMgCit, KCit, Placebo, KCl; KMgCit, KCl, KCit, Placebo; KMgCit, KCl, Placebo, KCit; KMgCit, Placebo, KCit, KCl; KMgCit, Placebo, KCl, KCit; Placebo, KCit, KCl, KMgCit; Placebo, KCit, KMgCit, KCl; Placebo, KCl, KCit, KMgCit; Placebo, KCl, KMgCit, KCit; Placebo, KMgCit, KCit, KCl; Placebo, KMgCit, KCl, KCit

Potassium magnesium citrate powder DRUG

1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Also known as: KMgCit

KCit, KCl, KMgCit, Placebo; KCit, KCl, Placebo, KMgCit; KCit, KMgCit, KCl, Placebo; KCit, KMgCit, Placebo, KCl; KCit, Placebo, KCl, KMgCit; KCit, Placebo, KMgCit, KCl; KCl, KCit, KMgCit, Placebo; KCl, KCit, Placebo, KMgCit; KCl, KMgCit, KCit, Placebo; KCl, KMgCit, Placebo, KCit; KCl, Placebo, KCit, KMgCit; KCl, Placebo, KMgCit, KCit; KMgCit, KCit, KCl, Placebo; KMgCit, KCit, Placebo, KCl; KMgCit, KCl, KCit, Placebo; KMgCit, KCl, Placebo, KCit; KMgCit, Placebo, KCit, KCl; KMgCit, Placebo, KCl, KCit; Placebo, KCit, KCl, KMgCit; Placebo, KCit, KMgCit, KCl; Placebo, KCl, KCit, KMgCit; Placebo, KCl, KMgCit, KCit; Placebo, KMgCit, KCit, KCl; Placebo, KMgCit, KCl, KCit

Placebo DRUG

1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Also known as: Microcystalline cellulose

KCit, KCl, KMgCit, Placebo; KCit, KCl, Placebo, KMgCit; KCit, KMgCit, KCl, Placebo; KCit, KMgCit, Placebo, KCl; KCit, Placebo, KCl, KMgCit; KCit, Placebo, KMgCit, KCl; KCl, KCit, KMgCit, Placebo; KCl, KCit, Placebo, KMgCit; KCl, KMgCit, KCit, Placebo; KCl, KMgCit, Placebo, KCit; KCl, Placebo, KCit, KMgCit; KCl, Placebo, KMgCit, KCit; KMgCit, KCit, KCl, Placebo; KMgCit, KCit, Placebo, KCl; KMgCit, KCl, KCit, Placebo; KMgCit, KCl, Placebo, KCit; KMgCit, Placebo, KCit, KCl; KMgCit, Placebo, KCl, KCit; Placebo, KCit, KCl, KMgCit; Placebo, KCit, KMgCit, KCl; Placebo, KCl, KCit, KMgCit; Placebo, KCl, KMgCit, KCit; Placebo, KMgCit, KCit, KCl; Placebo, KMgCit, KCl, KCit

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Hypertension Clinic - UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 27448942 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: John Poindexter
• Organization: UT Southwestern Medical Center at Dallas

john.poindexter@utsouthwestern.edu

2146486857

Study Officials

• Wanpen Vongpatanasin, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 11, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)