Effect of Magnesium Supplementation in COPD
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|ClinicalTrials.gov Identifier: NCT02680769|
Recruitment Status : Unknown
Verified June 2016 by University of Padova.
Recruitment status was: Recruiting
First Posted : February 12, 2016
Last Update Posted : June 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Dietary Supplement: 300 mg of citrate Mg Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Daily Supplementation of Magnesium Citrate in Moderate-severe Chronic Obstructive Pulmonary Disease: a Randomized, Controlled, Double-blind Trial|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2019|
300 mg of citrate Mg/daily
Dietary Supplement: 300 mg of citrate Mg
This group will take an oral supplementation of 300 mg of citrate magnesium
Placebo Comparator: Placebo
This group will take a placebo
- Change in forced expiratory volume in the 1st second between baseline and 6 months [ Time Frame: 0-3-6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680769
|Contact: Giuseppe Sergi, MDemail@example.com|
|University of Padova-Geriatrics Section||Recruiting|
|Padova, PD, Italy, 35128|
|Contact: Nicola Veronese, MD 00390498218492 firstname.lastname@example.org|