The Absorption of Magnesium Oxide Compared to Citrate in... | NCT00994006

Studies
The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

NCT00994006

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

May 4, 2011Estimated

Enrollment

41Actual

Phase

Phase 4

Conditions

Healthy Subjects
Hypomagnesemia

Interventions

Magnesium oxide
Magnesium citrate

Countries

Israel

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 2011

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 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Oct 11, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 14, 2009Estimated

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 3, 2011

Last Update Posted Date

May 4, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The magnesium food content in the Western world is consistently reducing. Hypomagnesemia is common in hospitalized patients, especially in the elderly with coronary artery disease (CAD) and/or those with chronic heart failure. Hypomagnesemia is associated with increased incidence of diabetes mellitus, metabolic syndrome, mortality rate from coronary artery disease (CAD) and all cause. Magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free radicals, improves human endothelial function and inhibits platelet function, including platelet aggregation and adhesion. The data regarding the absorption difference between supplemental magnesium oxide and magnesium citrate in humans is spare.

Detailed Description

Two oral preparations of magnesium are available in Israel:

Magnesium Diasporal (magnesium citrate, elemental magnesium 98.6 mg), PROTINA GMBH, ISMANING, Germany
Magnox 520 TM (magnesium oxide, 520 mg elemental magnesium), Naveh Pharma Ltd., Israel.

The data regarding the absorption difference between the two supplemental magnesium preparations (magnesium oxide and magnesium citrate) in humans is spare.

Primary objective: To find out the absorption of magnesium citrate compared to magnesium oxide in healthy subjects with no apparent heart disease.

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

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesium oxide tables	Active Comparator	Subjects will be instructed to take Magnox 520 qd	Dietary Supplement: Magnesium oxide
Magnesium citrate tablets	Active Comparator	Subjects will be instructed to take magnesium diasporal tablets t.i.d.	Dietary Supplement: Magnesium citrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium oxide	Dietary Supplement	520 mg of elemental magnesium q.d.	Magnesium oxide tables

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intracellular magnesium levels will be assessed		30-day

Secondary Outcomes

Measure	Description	Time Frame
Platelet function tests		30-day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-70 years
Healthy subjects

Exclusion Criteria:

Chest pain
Diabetes mellitus
Documented coronary artery disease
Asthma or any lung disease
Chronic diarrhea
Chronic renal failure (serum creatinine> 3 mg/dL)
Hypo or hyperthyroidism
Heart failure
On any chronic therapy/medications
Malabsorption
AV block
Pacemaker
Any malignancy
Obesity > 30 kg/m2 body mass index
Smokers
Pregnancy
Alcohol or drug abuse
Any chronic inflammation
Refuse to sign inform consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Shechter, MD, MA	The Leviev Heart Center, Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Leviev Heart Center, Chaim Sheba Medical Center		Tel Hashomer, Ramat Gan		52621	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20353903	Background	Shechter M. Magnesium and cardiovascular system. Magnes Res. 2010 Jun;23(2):60-72. doi: 10.1684/mrh.2010.0202. Epub 2010 Mar 31.
22433473	Derived	Shechter M, Saad T, Shechter A, Koren-Morag N, Silver BB, Matetzky S. Comparison of magnesium status using X-ray dispersion analysis following magnesium oxide and magnesium citrate treatment of healthy subjects. Magnes Res. 2012 Mar 1;25(1):28-39. doi: 10.1684/mrh.2012.0305.

ID	Term
D008277	Magnesium Oxide
C110422	magnesium citrate
C032246	levulinic acid

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D010087	Oxides
D017601	Oxygen Compounds