NCT01113138

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
2.6 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

April 27, 2010

Last Update Submit

January 10, 2014

Conditions

AsthmaChronic Obstructive Pulmonary Disease

Keywords

ClearanceHalf-lifeAbsorption fractionPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters

    Clearance, half-life \& absorption fraction

    Two years

Study Arms (3)

Baseline

NO INTERVENTION

Mablet

ACTIVE COMPARATOR
Dietary Supplement: Mablet (Magnesium-supplement)

Magnesium sulfate

ACTIVE COMPARATOR
Drug: Magnesium Sulfate

Interventions

Mablet (Magnesium-supplement)DIETARY_SUPPLEMENT

Mablet: Magnesium hydroxide/ -oxide (360 mg/tablet) 3 tablets as a single dose Produced by: Gunnar Kjems APS

Also known as: Mablet
Mablet
Magnesium SulfateDRUG

Solution for a single bolus-infusion, containing 2 grams of magnesium sulfate.

Also known as: Magnesiumsulfat 'SAD'
Magnesium sulfate

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Dept. of Respiratory Medicine, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (13)

  • Schlingmann KP, Konrad M, Seyberth HW. Genetics of hereditary disorders of magnesium homeostasis. Pediatr Nephrol. 2004 Jan;19(1):13-25. doi: 10.1007/s00467-003-1293-z. Epub 2003 Nov 22.

    PMID: 14634861BACKGROUND

  • Beasley R, Aldington S. Magnesium in the treatment of asthma. Curr Opin Allergy Clin Immunol. 2007 Feb;7(1):107-10. doi: 10.1097/ACI.0b013e328012ce4b.

    PMID: 17218820BACKGROUND

  • Emelyanov A, Fedoseev G, Barnes PJ. Reduced intracellular magnesium concentrations in asthmatic patients. Eur Respir J. 1999 Jan;13(1):38-40. doi: 10.1183/09031936.99.13103899.

    PMID: 10836320BACKGROUND

  • Dominguez LJ, Barbagallo M, Di Lorenzo G, Drago A, Scola S, Morici G, Caruso C. Bronchial reactivity and intracellular magnesium: a possible mechanism for the bronchodilating effects of magnesium in asthma. Clin Sci (Lond). 1998 Aug;95(2):137-42.

    PMID: 9680494BACKGROUND

  • Alamoudi OS. Hypomagnesaemia in chronic, stable asthmatics: prevalence, correlation with severity and hospitalization. Eur Respir J. 2000 Sep;16(3):427-31. doi: 10.1034/j.1399-3003.2000.016003427.x.

    PMID: 11028655BACKGROUND

  • Bede O, Suranyi A, Pinter K, Szlavik M, Gyurkovits K. Urinary magnesium excretion in asthmatic children receiving magnesium supplementation: a randomized, placebo-controlled, double-blind study. Magnes Res. 2003 Dec;16(4):262-70.

    PMID: 14979636BACKGROUND

  • Aziz HS, Blamoun AI, Shubair MK, Ismail MM, DeBari VA, Khan MA. Serum magnesium levels and acute exacerbation of chronic obstructive pulmonary disease: a retrospective study. Ann Clin Lab Sci. 2005 Autumn;35(4):423-7.

    PMID: 16254259BACKGROUND

  • Rowe BH, Camargo CA Jr. The role of magnesium sulfate in the acute and chronic management of asthma. Curr Opin Pulm Med. 2008 Jan;14(1):70-6. doi: 10.1097/MCP.0b013e3282f19867.

    PMID: 18043278BACKGROUND

  • 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.

    PMID: 15726901BACKGROUND

  • 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.

    PMID: 16788707BACKGROUND

  • 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.

    PMID: 14519140BACKGROUND

  • 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.

    PMID: 9387944BACKGROUND

  • 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.

    PMID: 16948990BACKGROUND

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Ronald Dahl, Professor

    Dept. of Respiratory Medicine, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 29, 2010

Study Start

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

DK(1)