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CompletedNCT01113151Updated Sep 4, 2013

Daily Magnesium-supplement for Severe Asthmatics

An interventional study of Mablet (Magnesium-supplement) and Placebo in Asthma, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-09-04.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Steroid-resistant
  • Severe asthmatics
  • Annual symptoms
  • Daily magnesium supplement
  • ACT (asthma control test)
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 5 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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 approximately one year,
  • various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
5 participants (actual)

Study arms

  • No intervention
    Washout
  • Active comparator
    Mablet

    Dietary Supplement: Mablet (Magnesium-supplement)

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • Dietary supplementMablet (Magnesium-supplement)

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

    Also known as: Mablet

  • OtherPlacebo

    3 placebo tablets daily for 12 weeks

06

What researchers measure

Primary outcomes

  1. Asthma control test (ACT)

    Questionnaire providing a level of disease control

    Time frame: Two years

Secondary outcomes

  1. EQ-5D

    Questionnaire providing a degree of quality of life

    Time frame: Two years

  2. Spirometry

    Lung function testing

    Time frame: Two years

  3. Reversibility testing

    Lung function reversibility testing with beta2-agonists

    Time frame: Two years

  4. Diary

    Participants will register asthma symptoms, use of reliever medication and exacerbations

    Time frame: Two years

  5. Adverse effects

    Time frame: Two years

  6. Blood- and urine samples

    Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine

    Time frame: Two years

  7. Endogen NO in expiratory breath and Impulse Oscillometry.

    Time frame: Two years

07

Study locations

1 site
  • Research Dept. of Respiratory Medicine, Aarhus University Hospital
    Aarhus C, 8000, Denmark
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References and documents

Publications

  • 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. PubMed 14634861 ↗
  • 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. PubMed 17218820 ↗
  • 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. PubMed 10836320 ↗
  • 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. PubMed 9680494 ↗
  • 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. PubMed 11028655 ↗
  • 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. PubMed 14979636 ↗
  • 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. PubMed 16254259 ↗
  • 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. PubMed 18043278 ↗
  • 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. PubMed 15726901 ↗
  • 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. PubMed 16788707 ↗
  • 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. PubMed 14519140 ↗
  • 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. PubMed 9387944 ↗
  • 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. Erratum In: Arch Bronconeumol. 2006 Oct;42(10):491. Spanish. PubMed 16948990 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01113151
Lead sponsor
University of Aarhus
Collaborators
Gunnar Kjems APS, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Aarhus University Hospital
Responsible party
Sponsor
First posted
Apr 29, 2010
Start date
Apr 2011
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Sep 4, 2013

Study contacts

Ronald Dahl, Professor
principal investigator · Dept. of Respiratory Medicine, Aarhus University Hospital, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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