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Effect of Magnesium Supplementation in COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
300 mg of citrate Mg
Placebo
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (>18 years).
  • Moderate-severe COPD (FEV1 between 30-80% of theorical values).

Exclusion Criteria:

  • Already taking magnesium or calcium supplementations.
  • Severe renal (creatinine clearance< 30 ml/min) or hepatic decline or presence of other co-morbidities interfering with outcomes (e.g. dementia).
  • Hypermagnesemia (serum Mg>1.85 mmol/L).

Sites / Locations

  • University of Padova-Geriatrics SectionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium

Placebo

Arm Description

300 mg of citrate Mg/daily

placebo group

Outcomes

Primary Outcome Measures

Change in forced expiratory volume in the 1st second between baseline and 6 months

Secondary Outcome Measures

Full Information

First Posted
February 8, 2016
Last Updated
June 10, 2016
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT02680769
Brief Title
Effect of Magnesium Supplementation in COPD
Official Title
Daily Supplementation of Magnesium Citrate in Moderate-severe Chronic Obstructive Pulmonary Disease: a Randomized, Controlled, Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. Subjects 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. These 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnesium
Arm Type
Experimental
Arm Description
300 mg of citrate Mg/daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo group
Intervention Type
Dietary Supplement
Intervention Name(s)
300 mg of citrate Mg
Intervention Description
This group will take an oral supplementation of 300 mg of citrate magnesium
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
This group will take a placebo
Primary Outcome Measure Information:
Title
Change in forced expiratory volume in the 1st second between baseline and 6 months
Time Frame
0-3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (>18 years). Moderate-severe COPD (FEV1 between 30-80% of theorical values). Exclusion Criteria: Already taking magnesium or calcium supplementations. Severe renal (creatinine clearance< 30 ml/min) or hepatic decline or presence of other co-morbidities interfering with outcomes (e.g. dementia). Hypermagnesemia (serum Mg>1.85 mmol/L).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Sergi, MD
Phone
00390498218492
Email
giuseppe.sergi@unipd.it
Facility Information:
Facility Name
University of Padova-Geriatrics Section
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Veronese, MD
Phone
00390498218492
Email
ilmannato@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16788707
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.
Results Reference
background
PubMed Identifier
17218820
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.
Results Reference
result
PubMed Identifier
16254259
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.
Results Reference
result
PubMed Identifier
34260036
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.
Results Reference
derived

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Effect of Magnesium Supplementation in COPD

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