Effect of Magnesium Supplementation in COPD

NCT ID: NCT02680769

Last Updated: 2016-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Magnesium

300 mg of citrate Mg/daily

Group Type EXPERIMENTAL

300 mg of citrate Mg

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

This group will take a placebo

Interventions

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300 mg of citrate Mg

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

This group will take a placebo

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Padova-Geriatrics Section

Padua, PD, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Sergi, MD

Role: CONTACT

00390498218492

Facility Contacts

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Nicola Veronese, MD

Role: primary

00390498218492

References

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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.

Reference Type BACKGROUND
PMID: 16788707 (View on PubMed)

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.

Reference Type RESULT
PMID: 17218820 (View on PubMed)

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.

Reference Type RESULT
PMID: 16254259 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34260036 (View on PubMed)

Other Identifiers

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3577

Identifier Type: -

Identifier Source: org_study_id

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