Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-08 @ 5:06 AM
Study NCT ID:
NCT02680769
Status:
UNKNOWN
Last Update Posted:
2016-06-13
First Post:
2016-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Magnesium Supplementation in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-10', 'studyFirstSubmitDate': '2016-02-08', 'studyFirstSubmitQcDate': '2016-02-08', 'lastUpdatePostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in forced expiratory volume in the 1st second between baseline and 6 months', 'timeFrame': '0-3-6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'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': '17218820', 'type': 'RESULT', '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': '16254259', 'type': 'RESULT', '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': '34260036', 'type': 'DERIVED', 'citation': 'Zanforlini BM, Ceolin C, Trevisan C, Alessi A, Seccia DM, Noale M, Maggi S, Guarnieri G, Vianello A, Sergi G. Clinical trial on the effects of oral magnesium supplementation in stable-phase COPD patients. Aging Clin Exp Res. 2022 Jan;34(1):167-174. doi: 10.1007/s40520-021-01921-z. Epub 2021 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'Magnesium (Mg) is involved in several pathways that could be affected in chronic obstructive pulmonary diseases (COPDs), namely in the contractility and excitability of neuro-muscolar endothelial cells and low-grade inflammation, a typical state of COPD. In this sense, several randomized controlled trials (RCTs) confirmed a positive role of Mg in asthma since long-period oral supplementation of Mg leads to a clinical and spirometric improvement.\n\nSubjects with COPD seem to have a reduced bioavailability of Mg probably due to the use of drugs that may increase Mg losses (e.g. beta-agonists and cortisones), to a reduced dietary Mg intake, and heavy smoking. A recent study showed that the administration of endovenous or aerosol Mg sulphate with beta-agonists acutely improve maximum expiratory flow during COPD relapses as well as the prolonged treatment with endovenous sulphate Mg led to a reduction in pulmonary hyperinflation and increase in muscles involved in respiration, with a consequent clinical and instrumental improvement.\n\nThese evidences suggest that a chronic supplementation with Mg could improve COPD in clinical and instrumental parameters, but, at the best of our knowledge, no study was available in this sense.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\>18 years).\n* Moderate-severe COPD (FEV1 between 30-80% of theorical values).\n\nExclusion Criteria:\n\n* Already taking magnesium or calcium supplementations.\n* Severe renal (creatinine clearance\\< 30 ml/min) or hepatic decline or presence of other co-morbidities interfering with outcomes (e.g. dementia).\n* Hypermagnesemia (serum Mg\\>1.85 mmol/L).'}, 'identificationModule': {'nctId': 'NCT02680769', 'briefTitle': 'Effect of Magnesium Supplementation in COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Daily Supplementation of Magnesium Citrate in Moderate-severe Chronic Obstructive Pulmonary Disease: a Randomized, Controlled, Double-blind Trial', 'orgStudyIdInfo': {'id': '3577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium', 'description': '300 mg of citrate Mg/daily', 'interventionNames': ['Dietary Supplement: 300 mg of citrate Mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo group', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '300 mg of citrate Mg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This group will take an oral supplementation of 300 mg of citrate magnesium', 'armGroupLabels': ['Magnesium']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'This group will take a placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'state': 'PD', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Veronese, MD', 'role': 'CONTACT', 'email': 'ilmannato@gmail.com', 'phone': '00390498218492'}], 'facility': 'University of Padova-Geriatrics Section', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Giuseppe Sergi, MD', 'role': 'CONTACT', 'email': 'giuseppe.sergi@unipd.it', 'phone': '00390498218492'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}