The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

S

Sheba Medical Center

Status and phase

Completed
Phase 4

Conditions

Healthy Subjects
Hypomagnesemia

Treatments

Dietary Supplement: Magnesium citrate
Dietary Supplement: Magnesium oxide

Study type

Interventional

Funder types

Other

Identifiers

NCT00994006
SHEBA-7339-09-SMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment

41 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

41 participants in 2 patient groups

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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