NCT02680769

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

February 8, 2016

Last Update Submit

June 10, 2016

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

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

    0-3-6 months

Study Arms (2)

Magnesium

EXPERIMENTAL

300 mg of citrate Mg/daily

Dietary Supplement: 300 mg of citrate Mg

Placebo

PLACEBO COMPARATOR

placebo group

Other: Placebo

Interventions

300 mg of citrate MgDIETARY_SUPPLEMENT

This group will take an oral supplementation of 300 mg of citrate magnesium

Magnesium
PlaceboOTHER

This group will take a placebo

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova-Geriatrics Section

Padua, PD, 35128, Italy

RECRUITING

Related Publications (4)

  • 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

  • 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: 17218820RESULT

  • 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: 16254259RESULT

  • 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.

    PMID: 34260036DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Giuseppe Sergi, MD

CONTACT

00390498218492giuseppe.sergi@unipd.it

Study Design

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

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 12, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

June 13, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)