The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

Phase 4

Completed

• Conditions: Healthy Subjects; Hypomagnesemia
• Interventions: Dietary Supplement: Magnesium oxide; Dietary Supplement: Magnesium citrate

• Registration Number: NCT00994006
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2009-10-11
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Study Start: 2010-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-03
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Magnesium oxide tables	Magnesium oxide	Subjects will be instructed to take Magnox 520 qd
Magnesium citrate tablets	Magnesium citrate	Subjects will be instructed to take magnesium diasporal tablets t.i.d.

Primary Outcome Measures

Name	Time	Method
Intracellular magnesium levels will be assessed	30-day

Secondary Outcome Measures

Name	Time	Method
Platelet function tests	30-day

Trial Locations

Locations (1)

The Leviev Heart Center, Chaim Sheba Medical Center; 🇮🇱 Tel Hashomer, Ramat Gan, Israel