Clinical trial NCT01113138: Study of the Metabolism of Two Magnesium Supplements in Healthy Volunteers
Official title: Pharmacokinetic Study of Mablet as Oral Supplement and Magnesium Sulfate as Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Keywords: Clearance
Half-life
Absorption fraction
Pharmacokinetics
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Gunnar Kjems APS
name: GCP-unit at Aarhus University Hospital, Aarhus, Denmark
name: Aarhus University Hospital
First posted: 2010-04-29
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.

The aim of this part of the project is to study the pharmacokinetics of the following two magnesium supplements:

* Mablet (dietary supplement)
* Magnesium Sulfate (solution for infusion)


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers.

Exclusion Criteria:

* Smokers,
* Using pharmaceuticals/supplements,
* Vegans/vegetarians,
* Major changes in eating habits within one week prior to study start.

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Research Dept. of Respiratory Medicine, Aarhus University Hospital
Study officials:
affiliation: Dept. of Respiratory Medicine, Aarhus University Hospital
name: Ronald Dahl, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nasulewicz A, Zimowska W, Bayle D, Dzimira S, Madej J, Rayssiguier Y, Opolski A, Mazur A. Changes in gene expression in the lungs of Mg-deficient mice are related to an inflammatory process. Magnes Res. 2004 Dec;17(4):259-63.
citation: Gontijo-Amaral C, Ribeiro MA, Gontijo LS, Condino-Neto A, Ribeiro JD. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial. Eur J Clin Nutr. 2007 Jan;61(1):54-60. doi: 10.1038/sj.ejcn.1602475. Epub 2006 Jun 21.
citation: Fogarty A, Lewis SA, Scrivener SL, Antoniak M, Pacey S, Pringle M, Britton J. Oral magnesium and vitamin C supplements in asthma: a parallel group randomized placebo-controlled trial. Clin Exp Allergy. 2003 Oct;33(10):1355-9. doi: 10.1046/j.1365-2222.2003.01777.x.
citation: Hill J, Micklewright A, Lewis S, Britton J. Investigation of the effect of short-term change in dietary magnesium intake in asthma. Eur Respir J. 1997 Oct;10(10):2225-9. doi: 10.1183/09031936.97.10102225.
citation: Abreu Gonzalez J, Hernandez Garcia C, Abreu Gonzalez P, Martin Garcia C, Jimenez A. [Effect of intravenous magnesium sulfate on chronic obstructive pulmonary disease exacerbations requiring hospitalization: a randomized placebo-controlled trial]. Arch Bronconeumol. 2006 Aug;42(8):384-7. doi: 10.1016/s1579-2129(06)60551-x. Spanish.