Bronchial Challenge Test of Magnesium-treated Asthmatics

NCT ID: NCT01118923

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-03-31

Brief Summary

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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 a 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 effect of a daily magnesium supplement on the grade of bronchial hyperreactivity in asthmatics.

Detailed Description

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Conditions

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Asthma

Keywords

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Bronchial challenge test Hyperreactivity PD20 for metacholine Daily magnesium supplement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Washout

Group Type NO_INTERVENTION

No interventions assigned to this group

Mablet

Group Type ACTIVE_COMPARATOR

Magnesium supplement (magnesium hydroxide/ -oxide)

Intervention Type DIETARY_SUPPLEMENT

3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

3 placebo-tablets daily for 12 weeks

Interventions

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Magnesium supplement (magnesium hydroxide/ -oxide)

3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS

Intervention Type DIETARY_SUPPLEMENT

Placebo

3 placebo-tablets daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Mablet

Eligibility Criteria

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Inclusion Criteria

* Asthma with annual symptoms, bronchial hyperreactivity and positive metacholine-test (PD20\<1000 microgram

Exclusion Criteria

* Se-Mg \> 2,00 mmol/L, smoking cessation less than 1 year prior to study start, major changes in eating habits within three months prior to study start and during the study period of approx. one year, various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gunnar Kjems APS

INDUSTRY

Sponsor Role collaborator

GCP-unit at Aarhus University Hospital, Aarhus, Denmark

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Dahl, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark

Locations

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Research Dept. of Respiratory Medicine, Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 14634861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17218820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10836320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9680494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11028655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14979636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16254259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18043278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15726901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16788707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14519140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9387944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16948990 (View on PubMed)

Other Identifiers

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9727d

Identifier Type: -

Identifier Source: org_study_id