The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-03-31

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.

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Detailed Description

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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.

Conditions

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Healthy Subjects Hypomagnesemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Magnesium oxide tables

Subjects will be instructed to take Magnox 520 qd

Group Type ACTIVE_COMPARATOR

Magnesium oxide

Intervention Type DIETARY_SUPPLEMENT

520 mg of elemental magnesium q.d.

Magnesium citrate tablets

Subjects will be instructed to take magnesium diasporal tablets t.i.d.

Group Type ACTIVE_COMPARATOR

Magnesium citrate

Intervention Type DIETARY_SUPPLEMENT

Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.

Interventions

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Magnesium oxide

520 mg of elemental magnesium q.d.

Intervention Type DIETARY_SUPPLEMENT

Magnesium citrate

Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Magnox 520 TM Magnesium Diasporal

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes