NCT00994006

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

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

First Submitted

Initial submission to the registry

October 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 4, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

October 11, 2009

Last Update Submit

May 3, 2011

Conditions

Healthy SubjectsHypomagnesemia

Keywords

Magnesiumnutritionplateletsaggregation

Outcome Measures

Primary Outcomes (1)

  • Intracellular magnesium levels will be assessed

    30-day

Secondary Outcomes (1)

  • Platelet function tests

    30-day

Study Arms (2)

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

Magnesium oxideDIETARY_SUPPLEMENT

520 mg of elemental magnesium q.d.

Also known as: Magnox 520 TM
Magnesium oxide tables
Magnesium citrateDIETARY_SUPPLEMENT

Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.

Also known as: Magnesium Diasporal
Magnesium citrate tablets

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-70 years
  • Healthy subjects

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Leviev Heart Center, Chaim Sheba Medical Center

Tel Hashomer, Ramat Gan, 52621, Israel

Location

Related Publications (2)

  • Shechter M. Magnesium and cardiovascular system. Magnes Res. 2010 Jun;23(2):60-72. doi: 10.1684/mrh.2010.0202. Epub 2010 Mar 31.

    PMID: 20353903BACKGROUND

  • 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.

    PMID: 22433473DERIVED

MeSH Terms

Interventions

Magnesium Oxidemagnesium citratelevulinic acid

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Michael Shechter, MD, MA

    The Leviev Heart Center, Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 11, 2009

First Posted

October 14, 2009

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 4, 2011

Record last verified: 2011-05

Locations

IL(1)