NCT01113151

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 a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease. The aim of this part of the project is to reveal possible beneficial effects of daily magnesium supplement for severe asthmatics, refractory to conventional treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Apr 2011

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
11 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

April 27, 2010

Last Update Submit

September 3, 2013

Conditions

Asthma

Keywords

Steroid-resistantSevere asthmaticsAnnual symptomsDaily magnesium supplementACT (asthma control test)

Outcome Measures

Primary Outcomes (1)

  • Asthma control test (ACT)

    Questionnaire providing a level of disease control

    Two years

Secondary Outcomes (7)

  • EQ-5D

    Two years

  • Spirometry

    Two years

  • Reversibility testing

    Two years

  • Diary

    Two years

  • Adverse effects

    Two years

  • +2 more secondary outcomes

Study Arms (3)

Washout

NO INTERVENTION

Mablet

ACTIVE COMPARATOR
Dietary Supplement: Mablet (Magnesium-supplement)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Mablet (Magnesium-supplement)DIETARY_SUPPLEMENT

3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS

Also known as: Mablet
Mablet
PlaceboOTHER

3 placebo tablets daily for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe asthmatics, refractory to conventional treatment, including systemic steroid treatment; symptoms must be annual.

You may not qualify if:

  • 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 approximately one year,
  • various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.

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

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ronald Dahl, Professor

    Dept. of Respiratory Medicine, Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 29, 2010

Study Start

April 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

DK(1)