NCT02653560

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Sep 2012

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 28, 2016

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

2.3 years

First QC Date

January 8, 2016

Results QC Date

May 10, 2016

Last Update Submit

October 12, 2023

Conditions

Hypertension

Keywords

PotassiumMagnesiumCitrateDASH

Outcome Measures

Primary Outcomes (1)

  • 24-hour Average Systolic Blood Pressure

    Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.

    4 weeks

Study Arms (4)

Potassium magnesium Citrate (KMgCit) arm

EXPERIMENTAL

Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks

Drug: Potassium magnesium Citrate (KMgCit)

Potassium citrate arm

EXPERIMENTAL

A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.

Drug: Potassium citrate powder

Potassium chloride arm

EXPERIMENTAL

Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks

Drug: Potassium chloride powder

Placebo

PLACEBO COMPARATOR

Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.

Drug: Placebo

Interventions

Potassium chloride powderDRUG
Potassium chloride arm
Potassium magnesium Citrate (KMgCit)DRUG
Potassium magnesium Citrate (KMgCit) arm
Potassium citrate powderDRUG
Also known as: Urocit®-K powder
Potassium citrate arm
PlaceboDRUG
Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (7)

  • He FJ, Markandu ND, Coltart R, Barron J, MacGregor GA. Effect of short-term supplementation of potassium chloride and potassium citrate on blood pressure in hypertensives. Hypertension. 2005 Apr;45(4):571-4. doi: 10.1161/01.HYP.0000158264.36590.19. Epub 2005 Feb 21.

    PMID: 15723964RESULT

  • Conlin PR, Erlinger TP, Bohannon A, Miller ER 3rd, Appel LJ, Svetkey LP, Moore TJ. The DASH diet enhances the blood pressure response to losartan in hypertensive patients. Am J Hypertens. 2003 May;16(5 Pt 1):337-42. doi: 10.1016/s0895-7061(03)00056-6.

    PMID: 12745193RESULT

  • He FJ, Marciniak M, Carney C, Markandu ND, Anand V, Fraser WD, Dalton RN, Kaski JC, MacGregor GA. Effects of potassium chloride and potassium bicarbonate on endothelial function, cardiovascular risk factors, and bone turnover in mild hypertensives. Hypertension. 2010 Mar;55(3):681-8. doi: 10.1161/HYPERTENSIONAHA.109.147488. Epub 2010 Jan 18.

    PMID: 20083724RESULT

  • Lin PH, Aickin M, Champagne C, Craddick S, Sacks FM, McCarron P, Most-Windhauser MM, Rukenbrod F, Haworth L; Dash-Sodium Collaborative Research Group. Food group sources of nutrients in the dietary patterns of the DASH-Sodium trial. J Am Diet Assoc. 2003 Apr;103(4):488-96. doi: 10.1053/jada.2003.50065.

    PMID: 12669013RESULT

  • Lind L, Lithell H, Pollare T, Ljunghall S. Blood pressure response during long-term treatment with magnesium is dependent on magnesium status. A double-blind, placebo-controlled study in essential hypertension and in subjects with high-normal blood pressure. Am J Hypertens. 1991 Aug;4(8):674-9. doi: 10.1093/ajh/4.8.674.

    PMID: 1930849RESULT

  • China Salt Substitute Study Collaborative Group. Salt substitution: a low-cost strategy for blood pressure control among rural Chinese. A randomized, controlled trial. J Hypertens. 2007 Oct;25(10):2011-8. doi: 10.1097/HJH.0b013e3282b9714b.

    PMID: 17885542RESULT

  • Sellmeyer DE, Schloetter M, Sebastian A. Potassium citrate prevents increased urine calcium excretion and bone resorption induced by a high sodium chloride diet. J Clin Endocrinol Metab. 2002 May;87(5):2008-12. doi: 10.1210/jcem.87.5.8470.

    PMID: 11994333RESULT

MeSH Terms

Conditions

Hypertension

Interventions

potassium-magnesium citrate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr Wanpen Vongpatanasin
Organization
UT Southwestern Medical Center
wanpen.vongpatanasin@utsouthwestern.edu
2146489078

Study Officials

  • Wanpen Vongpatanasin, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

September 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 16, 2023

Results First Posted

July 28, 2016

Record last verified: 2023-10

Locations

US(1)