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NCT00994006 Clinical Trial

The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00994006
Other study ID # SHEBA-7339-09-SMC
Secondary ID
Status Completed
Phase Phase 4
First received October 11, 2009
Last updated May 3, 2011
Start date January 2010
Est. completion date March 2011

Study information
Verified date May 2011
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Magnesium oxide
520 mg of elemental magnesium q.d.
• Magnesium citrate
Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.

Locations
Country Name City State
Israel The Leviev Heart Center, Chaim Sheba Medical Center Tel Hashomer, Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Shechter M. Magnesium and cardiovascular system. Magnes Res. 2010 Jun;23(2):60-72. doi: 10.1684/mrh.2010.0202. Epub 2010 Mar 31. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intracellular magnesium levels will be assessed 30-day Yes
Secondary Platelet function tests 30-day No
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