The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT00994006
• Recruitment Status: Completed
• First Posted: October 14, 2009
• Last Update Posted: May 4, 2011
• Sponsor: Sheba Medical Center
• Information provided by: Sheba Medical Center

Tracking Information

• First Submitted Date: October 11, 2009
• First Posted Date: October 14, 2009
• Last Update Posted Date: May 4, 2011
• Study Start Date: January 2010
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 13, 2009): Intracellular magnesium levels will be assessed [ Time Frame: 30-day ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 13, 2009): Platelet function tests [ Time Frame: 30-day ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Healthy Subjects
• Hypomagnesemia

Intervention

• Dietary Supplement: Magnesium oxide
  520 mg of elemental magnesium q.d.
  Other Name: Magnox 520 TM
• Dietary Supplement: Magnesium citrate
  Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.
  Other Name: Magnesium Diasporal

Study Arms

• Active Comparator: Magnesium oxide tables
  Subjects will be instructed to take Magnox 520 qd
  Intervention: Dietary Supplement: Magnesium oxide
• Active Comparator: Magnesium citrate tablets
  Subjects will be instructed to take magnesium diasporal tablets t.i.d.
  Intervention: Dietary Supplement: Magnesium citrate

Publications *

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2011): 41
• Original Estimated Enrollment (submitted: October 13, 2009): 40
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00994006
• Other Study ID Numbers: SHEBA-7339-09-SMC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Michael Shechter, MD, MA, PI, Leviev Heart Center, Sheba Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Sheba Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Shechter, MD, MA; The Leviev Heart Center, Sheba Medical Center

• PRS Account: Sheba Medical Center
• Verification Date: May 2011