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History of Changes for Study: NCT00994006
The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects
Latest version (submitted May 3, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 13, 2009 None (earliest Version on record)
2 November 18, 2009 Study Status
3 December 14, 2009 Study Status
4 January 31, 2010 Recruitment Status, Study Status and Contacts/Locations
5 August 11, 2010 Study Status and References
6 May 3, 2011 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:
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Study NCT00994006
Submitted Date:  October 13, 2009 (v1)
Open or close this module Study Identification
Unique Protocol ID: SHEBA-7339-09-SMC
Brief Title: The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects
Official Title: The Absorption of Supplemental Magnesium Oxide Compared to Magnesium Citrate in Healthy Subjects With no Apparent Heart Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2009
Overall Status: Not yet recruiting
Study Start: November 2009
Primary Completion: November 2010 [Anticipated]
Study Completion: December 2010 [Anticipated]
First Submitted: October 11, 2009
First Submitted that
Met QC Criteria:		 October 13, 2009
First Posted: October 14, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:		 October 13, 2009
Last Update Posted: October 14, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sheba Medical Center
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:

  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.
Open or close this module Conditions
Conditions: Healthy Subjects
Hypomagnesemia
Keywords: Magnesium
nutrition
platelets
aggregation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
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 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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Intracellular magnesium levels will be assessed
[ Time Frame: 30-day ]
Secondary Outcome Measures:
1. Platelet function tests
[ Time Frame: 30-day ]
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Micahel Shechter, MD, MA
Telephone: +972-3-5302617
Email: shechter@sheba.health.gov.il
Central Contact Backup: Shlomi Matetzky, MD
Telephone: +972-3-5302504
Email: Shlomi.matetzky@sheba.health.gov.il
Study Officials: Michael Shechter, MD, MA
Principal Investigator
The Leviev Heart Center, Sheba Medical Center
Locations: Israel
The Leviev Heart Center, Chaim Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel, 52621
Contact:Contact: Michael Shechter, MD, MA +972-3-5302617 shechter@sheba.health.gov.il
Contact:Contact: Shlomi Matetzky, MD +972-3-5302504 Shlomi.matetzky@sheba.health.gov.il
Contact:Sub-Investigator: Alon Shechter, MD
Contact:Sub-Investigator: Shlomi Matetzky, MD
Contact:Principal Investigator: Michael Shechter, MD, MA
Contact:Sub-Investigator: Yehuda Shoenfeld, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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