The Use of Magnesium to Improve Blood Pressure, Cholester... | NCT00282659

Studies
The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control

NCT00282659

Sponsor

Hartford Hospital

Status

Completed

Last Update Posted

May 21, 2019Actual

Enrollment

240Actual

Phase

Phase 4

Conditions

Coronary Artery Disease
Hypertension
Dyslipidemia
Diabetes

Interventions

magnesium L-lactate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jan 25, 2006

First Submission Date that Met QC Criteria

Jan 25, 2006

First Posted Date

Jan 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2019

Last Update Posted Date

May 21, 2019Actual

Description Module

Brief Summary

The purpose of this study is to determine if magnesium can improve blood pressure, cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators (ICDs).

Detailed Description

Magnesium is the second most abundant intracellular cation and plays a vital role in many physiologic processes. It has been determined that patients with cardiovascular disease have intracellular magnesium (Mgi) deficiencies. Among the ICD registries in Europe and the United States 64% and 77% of patients also carry the diagnosis of CAD, respectively. Patients with CAD have risk factors that lead to the development and or propagation of atherosclerosis. Paramount among these risk factors are hypertension, dyslipidemia, and diabetes.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the effect they have on cholesterol, blood pressure, and blood glucose.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Name	Type	Description	Arm Group Labels	Other Names
magnesium L-lactate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure, cardiac output, systemic vascular resistance, thoracic fluid content, total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, and blood glucose		at baseline, 3, and 6 months of follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly implanted ICD or recent ICD shock (within 6 months)

Exclusion Criteria:

Inability to swallow
A non-cardiac disease with a survival prognosis of less than 12 months
Hypermagnesemia
Creatinine clearance less than 30mL/min
Lactic acidosis or systemic acidosis syndrome
Previous intolerance to magnesium L-lactate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles M White, PharmD	University of Connecticut School of Pharmacy, Hartford Hospital Division of Drug Information	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hartford Hospital		Hartford	Connecticut	06102-5037	United States

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D006973	Hypertension
D050171	Dyslipidemias
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided