This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00994006
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:
Sheba Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Hypomagnesemia Dietary Supplement: Magnesium oxide Dietary Supplement: Magnesium citrate Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Absorption of Supplemental Magnesium Oxide Compared to Magnesium Citrate in Healthy Subjects With no Apparent Heart Disease
Study Start Date : January 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994006


Locations
Layout table for location information
Israel
The Leviev Heart Center, Chaim Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Michael Shechter, MD, MA The Leviev Heart Center, Sheba Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

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

Layout table for additonal information
Responsible Party: Michael Shechter, MD, MA, PI, Leviev Heart Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00994006    
Other Study ID Numbers: SHEBA-7339-09-SMC
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2011
Keywords provided by Sheba Medical Center:
Magnesium
nutrition
platelets
aggregation
Additional relevant MeSH terms:
Layout table for MeSH terms
Magnesium citrate
Magnesium Oxide
Levulinic acid
Molecular Mechanisms of Pharmacological Action
 Cathartics
Gastrointestinal Agents
Antacids
Enzyme Inhibitors