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The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00994006
First received: October 11, 2009
Last updated: May 3, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Hypomagnesemia
 Dietary Supplement: Magnesium oxide
Dietary Supplement: Magnesium citrate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Absorption of Supplemental Magnesium Oxide Compared to Magnesium Citrate in Healthy Subjects With no Apparent Heart Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Intracellular magnesium levels will be assessed [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Platelet function tests [ Time Frame: 30-day ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Magnesium Diasporal

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994006

Locations
Israel
The Leviev Heart Center, Chaim Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Michael Shechter, MD, MA The Leviev Heart Center, Sheba Medical Center
  More Information

Additional Information:
The Leviev Heart Center  This link exits the ClinicalTrials.gov site

Publications:
Shechter M. Magnesium and cardiovscular system. Magnes Res. 2010 Jun;23(2):60-72. Epub 2010 Mar 31

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Shechter, MD, MA, PI, Leviev Heart Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00994006     History of Changes
Other Study ID Numbers: SHEBA-7339-09-SMC
Study First Received: October 11, 2009
Last Updated: May 3, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Magnesium
nutrition
platelets
aggregation

Additional relevant MeSH terms:
Citric Acid
Levulinic acid
Magnesium Oxide
Magnesium citrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Antacids
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013