Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT01113151
Status:
COMPLETED
Last Update Posted:
2013-09-04
First Post:
2010-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daily Magnesium-supplement for Severe Asthmatics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-03', 'studyFirstSubmitDate': '2010-04-27', 'studyFirstSubmitQcDate': '2010-04-28', 'lastUpdatePostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma control test (ACT)', 'timeFrame': 'Two years', 'description': 'Questionnaire providing a level of disease control'}], 'secondaryOutcomes': [{'measure': 'EQ-5D', 'timeFrame': 'Two years', 'description': 'Questionnaire providing a degree of quality of life'}, {'measure': 'Spirometry', 'timeFrame': 'Two years', 'description': 'Lung function testing'}, {'measure': 'Reversibility testing', 'timeFrame': 'Two years', 'description': 'Lung function reversibility testing with beta2-agonists'}, {'measure': 'Diary', 'timeFrame': 'Two years', 'description': 'Participants will register asthma symptoms, use of reliever medication and exacerbations'}, {'measure': 'Adverse effects', 'timeFrame': 'Two years'}, {'measure': 'Blood- and urine samples', 'timeFrame': 'Two years', 'description': 'Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine'}, {'measure': 'Endogen NO in expiratory breath and Impulse Oscillometry.', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Steroid-resistant', 'Severe asthmatics', 'Annual symptoms', 'Daily magnesium supplement', 'ACT (asthma control test)'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '14634861', 'type': 'BACKGROUND', 'citation': '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': '17218820', 'type': 'BACKGROUND', 'citation': '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': '10836320', 'type': 'BACKGROUND', 'citation': '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': '9680494', 'type': 'BACKGROUND', 'citation': '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': '11028655', 'type': 'BACKGROUND', 'citation': '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': '14979636', 'type': 'BACKGROUND', 'citation': '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': '16254259', 'type': 'BACKGROUND', 'citation': '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': '18043278', 'type': 'BACKGROUND', 'citation': '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': '15726901', 'type': 'BACKGROUND', '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.'}, {'pmid': '16788707', 'type': 'BACKGROUND', '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.'}, {'pmid': '14519140', 'type': 'BACKGROUND', '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.'}, {'pmid': '9387944', 'type': 'BACKGROUND', '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.'}, {'pmid': '16948990', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe aim of this part of the project is to reveal possible beneficial effects of daily magnesium supplement for severe asthmatics, refractory to conventional treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe asthmatics, refractory to conventional treatment, including systemic steroid treatment; symptoms must be annual.\n\nExclusion Criteria:\n\n* Se-Mg \\> 2,00 mmol/L,\n* smoking cessation less than 1 year prior to study start,\n* major changes in eating habits within three months prior to study start and during the study period of approximately one year,\n* various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.'}, 'identificationModule': {'nctId': 'NCT01113151', 'briefTitle': 'Daily Magnesium-supplement for Severe Asthmatics', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Daily Magnesium-supplement With Mablet for Steroid-resistant, Severe Asthmatics', 'orgStudyIdInfo': {'id': '9727c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Washout'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mablet', 'interventionNames': ['Dietary Supplement: Mablet (Magnesium-supplement)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Mablet (Magnesium-supplement)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Mablet'], 'description': '3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS', 'armGroupLabels': ['Mablet']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '3 placebo tablets daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Research Dept. of Respiratory Medicine, Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Ronald Dahl, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Respiratory Medicine, Aarhus University Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gunnar Kjems APS', 'class': 'INDUSTRY'}, {'name': 'GCP-unit at Aarhus University Hospital, Aarhus, Denmark', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}