The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Subjects, Hypomagnesemia

Intervention / Treatment
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* Dietary Supplement: Magnesium oxide
* Dietary Supplement: Magnesium citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium oxide tables<br>Subjects will be instructed to take Magnox 520 qd | Dietary Supplement: Magnesium oxide<br>* 520 mg of elemental magnesium q.d.<br>* Other names: Magnox 520 TM;|
| Active Comparator: Magnesium citrate tablets<br>Subjects will be instructed to take magnesium diasporal tablets t.i.d. | Dietary Supplement: Magnesium citrate<br>* Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.<br>* Other names: Magnesium Diasporal;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function tests |  | 30-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnesium, nutrition, platelets, aggregation