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Completed

NCT Number: NCT00994006

The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

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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Key information

Conditions

Healthy Subjects Hypomagnesemia

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Leviev Heart Center, Chaim Sheba Medical Center

Tel Hashomer, Ramat Gan, 52621, Israel

About this study

Two oral preparations of magnesium are available in Israel:

  • Magnesium Diasporal (magnesium citrate, elemental magnesium 98.6 mg), PROTINA GMBH, ISMANING, Germany
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-70 years
  • Healthy subjects

Exclusion criteria

  • Chest pain
  • Diabetes mellitus
  • Documented coronary artery disease
  • Asthma or any lung disease
  • Chronic diarrhea
  • Chronic renal failure (serum creatinine> 3 mg/dL)
  • Hypo or hyperthyroidism
  • Heart failure
  • On any chronic therapy/medications
  • Malabsorption
  • AV block
  • Pacemaker
  • Any malignancy
  • Obesity > 30 kg/m2 body mass index
  • Smokers
  • Pregnancy
  • Alcohol or drug abuse
  • Any chronic inflammation
  • Refuse to sign inform consent

Treatment and study plan

Magnesium oxide

Dietary Supplement

520 mg of elemental magnesium q.d.

Other names: Magnox 520 TM

Magnesium citrate

Dietary Supplement

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

Other names: Magnesium Diasporal

Primary outcomes

  1. Intracellular magnesium levels will be assessed

    Time frame: 30-day

Secondary outcomes

  1. Platelet function tests

    Time frame: 30-day

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2009
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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