Clinical trial NCT00994006: The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects
Official title: The Absorption of Supplemental Magnesium Oxide Compared to Magnesium Citrate in Healthy Subjects With no Apparent Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Subjects
Hypomagnesemia
Keywords: Magnesium
nutrition
platelets
aggregation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-10-14
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Intracellular magnesium levels will be assessed
timeFrame: 30-day
Secondary outcomes:
measure: Platelet function tests
timeFrame: 30-day
Other outcomes:
Locations:
city: Tel Hashomer, Ramat Gan
country: Israel
facility: The Leviev Heart Center, Chaim Sheba Medical Center
Study officials:
affiliation: The Leviev Heart Center, Sheba Medical Center
name: Michael Shechter, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shechter M. Magnesium and cardiovascular system. Magnes Res. 2010 Jun;23(2):60-72. doi: 10.1684/mrh.2010.0202. Epub 2010 Mar 31.
citation: 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.