- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00994006
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:
- Magnesium Diasporal (magnesium citrate, elemental magnesium 98.6 mg), PROTINA GMBH, ISMANING, Germany
- 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
-
-
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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:
- Age 20-70 years
- Healthy subjects
Exclusion Criteria:
- 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
- Pregnancy
- Alcohol or drug abuse
- Any chronic inflammation
- 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
|
520 mg of elemental magnesium q.d.
Other Names:
|
Active Comparator: Magnesium citrate tablets
Subjects will be instructed to take magnesium diasporal tablets t.i.d.
|
Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.
Other Names:
|
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
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
- Shechter M. Magnesium and cardiovascular system. Magnes Res. 2010 Jun;23(2):60-72. doi: 10.1684/mrh.2010.0202. Epub 2010 Mar 31.
- 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.
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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