The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

May 3, 2011 updated by: Sheba Medical Center

The Absorption of Supplemental Magnesium Oxide Compared to Magnesium Citrate in Healthy Subjects With no Apparent Heart Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two oral preparations of magnesium are available in Israel:

  1. Magnesium Diasporal (magnesium citrate, elemental magnesium 98.6 mg), PROTINA GMBH, ISMANING, Germany
  2. 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Ramat Gan, Israel, 52621
        • The Leviev Heart Center, Chaim Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 20-70 years
  2. Healthy subjects

Exclusion Criteria:

  1. Chest pain
  2. Diabetes mellitus
  3. Documented coronary artery disease
  4. Asthma or any lung disease
  5. Chronic diarrhea
  6. Chronic renal failure (serum creatinine> 3 mg/dL)
  7. Hypo or hyperthyroidism
  8. Heart failure
  9. On any chronic therapy/medications
  10. Malabsorption
  11. AV block
  12. Pacemaker
  13. Any malignancy
  14. Obesity > 30 kg/m2 body mass index
  15. Smokers
  16. Pregnancy
  17. Alcohol or drug abuse
  18. Any chronic inflammation
  19. Refuse to sign inform consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium oxide tables
Subjects will be instructed to take Magnox 520 qd
Dietary supplement: Magnesium oxide
520 mg of elemental magnesium q.d.
Other Names:
  • Magnox 520 TM
Active Comparator: Magnesium citrate tablets
Subjects will be instructed to take magnesium diasporal tablets t.i.d.
Dietary supplement: Magnesium citrate
Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.
Other Names:
  • Magnesium Diasporal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Platelet function tests
Time Frame: 30-day
30-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Michael Shechter, MD, MA, The Leviev Heart Center, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 11, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

May 3, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-7339-09-SMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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