COPDNCT01118936
Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease
A study testing Magnesium supplement (magnesium hydroxide/ -oxide) in people with COPD, run by University of Aarhus at 1 site in Denmark.
Trial summary
The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- COPD
- What is being tested?
- Magnesium supplement (magnesium hydroxide/ -oxide)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD-patients, grade moderate-severe (FEV1 30-80 % of expected. FEV1/FVC < 0,7).
Who cannot join
- Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, submission to hospital within the last two years, submission to hospital with exacerbation during the study period, major changes in eating habits within three months prior to study start and during the study period of approx.one year various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Dept. of Respiratory Medicine, Aarhus University Hospital
Aarhus C, 8000
About this study
Official title: Daily Mablet-treatment of Patients With COPD
The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.
The aim of this part of the project is to study the effect of a daily magnesium supplement for COPD-patients
- Conditions
- COPD
- Being tested
- Magnesium supplement (magnesium hydroxide/ -oxide), Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, Daily magnesium supplement, EQ-5D
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium supplement (magnesium hydroxide/ -oxide)Dietary supplement
Also called Mablet
3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
PlaceboDietary supplement
3 tablets of placebo daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Washout | No intervention | Not described |
| Mablet | Active comparator | Not described Receives: Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D
Questionnaire providing a degree of quality of life
Measured: Two years
Secondary outcomes (7)
Spirometry
Lung function testing
Measured: Two years
Diary
Participants will register COPD symptoms, use of reliever medication and exacerbations
Measured: Two years
Adverse effects
Measured: Two years
6 minutes walking test - walking distance within 6 minutes (measured in meters)
Measured: Two years
'Medical Research Council Dyspnea Scale' (MRC)
Acknowledged international scale for measuring the level of dyspnea and physical capability of patients with COPD
Measured: Two years
Endogen NO in expiratory breath and Impulse Oscillometry.
Measured: Two years
Blood- and urine samples
Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Gunnar Kjems APS, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Ronald Dahl, Professor, Principal investigator, Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118936
- Sponsor's protocol ID
- 9727e
- Status last verified
- Sep 2013
- First submitted
- 27 Apr 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schlingmann KP, Konrad M, Seyberth HW. Genetics of hereditary disorders of magnesium homeostasis. Pediatr Nephrol. 2004 Jan;19(1):13-25. doi: 10.1007/s00467-003-1293-z. Epub 2003 Nov 22.
PubMed 14634861Beasley 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.
PubMed 17218820Emelyanov A, Fedoseev G, Barnes PJ. Reduced intracellular magnesium concentrations in asthmatic patients. Eur Respir J. 1999 Jan;13(1):38-40. doi: 10.1183/09031936.99.13103899.
PubMed 10836320Dominguez LJ, Barbagallo M, Di Lorenzo G, Drago A, Scola S, Morici G, Caruso C. Bronchial reactivity and intracellular magnesium: a possible mechanism for the bronchodilating effects of magnesium in asthma. Clin Sci (Lond). 1998 Aug;95(2):137-42.
PubMed 9680494Alamoudi OS. Hypomagnesaemia in chronic, stable asthmatics: prevalence, correlation with severity and hospitalization. Eur Respir J. 2000 Sep;16(3):427-31. doi: 10.1034/j.1399-3003.2000.016003427.x.
PubMed 11028655Bede O, Suranyi A, Pinter K, Szlavik M, Gyurkovits K. Urinary magnesium excretion in asthmatic children receiving magnesium supplementation: a randomized, placebo-controlled, double-blind study. Magnes Res. 2003 Dec;16(4):262-70.
PubMed 14979636Aziz 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.
PubMed 16254259Rowe BH, Camargo CA Jr. The role of magnesium sulfate in the acute and chronic management of asthma. Curr Opin Pulm Med. 2008 Jan;14(1):70-6. doi: 10.1097/MCP.0b013e3282f19867.
PubMed 18043278Nasulewicz A, Zimowska W, Bayle D, Dzimira S, Madej J, Rayssiguier Y, Opolski A, Mazur A. Changes in gene expression in the lungs of Mg-deficient mice are related to an inflammatory process. Magnes Res. 2004 Dec;17(4):259-63.
PubMed 15726901Gontijo-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.
PubMed 16788707Fogarty A, Lewis SA, Scrivener SL, Antoniak M, Pacey S, Pringle M, Britton J. Oral magnesium and vitamin C supplements in asthma: a parallel group randomized placebo-controlled trial. Clin Exp Allergy. 2003 Oct;33(10):1355-9. doi: 10.1046/j.1365-2222.2003.01777.x.
PubMed 14519140Hill J, Micklewright A, Lewis S, Britton J. Investigation of the effect of short-term change in dietary magnesium intake in asthma. Eur Respir J. 1997 Oct;10(10):2225-9. doi: 10.1183/09031936.97.10102225.
PubMed 9387944Abreu Gonzalez J, Hernandez Garcia C, Abreu Gonzalez P, Martin Garcia C, Jimenez A. [Effect of intravenous magnesium sulfate on chronic obstructive pulmonary disease exacerbations requiring hospitalization: a randomized placebo-controlled trial]. Arch Bronconeumol. 2006 Aug;42(8):384-7. doi: 10.1016/s1579-2129(06)60551-x. Spanish.
PubMed 16948990
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Mablet-treatment of Patients With COPD
- ClinicalTrials.gov ID
- NCT01118936
- Acronym / sponsor ID
- 9727e
- Conditions
- COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, Daily magnesium supplement, EQ-5D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Gunnar Kjems APS, Aarhus University Hospital
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.
The aim of this part of the project is to study the effect of a daily magnesium supplement for COPD-patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Washout | No intervention | – |
| Mablet | Active comparator | Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD-patients, grade moderate-severe (FEV1 30-80 % of expected. FEV1/FVC < 0,7).
Key exclusion criteria (1 listed)
- Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, submission to hospital within the last two years, submission to hospital with exacerbation during the study period, major changes in eating habits within three months prior to study start and during the study period of approx.one year various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium supplement (magnesium hydroxide/ -oxide)Also: Mablet3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS | Dietary supplement | Mablet |
| Placebo3 tablets of placebo daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
EQ-5D
Time frame: Two years
Questionnaire providing a degree of quality of life
7 secondary outcomes
Spirometry
Time frame: Two years
Diary
Time frame: Two years
Adverse effects
Time frame: Two years
6 minutes walking test - walking distance within 6 minutes (measured in meters)
Time frame: Two years
'Medical Research Council Dyspnea Scale' (MRC)
Time frame: Two years
Endogen NO in expiratory breath and Impulse Oscillometry.
Time frame: Two years
Blood- and urine samples
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Background: PubMed 14634861Schlingmann KP, Konrad M, Seyberth HW. Genetics of hereditary disorders of magnesium homeostasis. Pediatr Nephrol. 2004 Jan;19(1):13-25. doi: 10.1007/s00467-003-1293-z. Epub 2003 Nov 22.
- Background: PubMed 17218820Beasley 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.
- Background: PubMed 10836320Emelyanov A, Fedoseev G, Barnes PJ. Reduced intracellular magnesium concentrations in asthmatic patients. Eur Respir J. 1999 Jan;13(1):38-40. doi: 10.1183/09031936.99.13103899.
- Background: PubMed 9680494Dominguez LJ, Barbagallo M, Di Lorenzo G, Drago A, Scola S, Morici G, Caruso C. Bronchial reactivity and intracellular magnesium: a possible mechanism for the bronchodilating effects of magnesium in asthma. Clin Sci (Lond). 1998 Aug;95(2):137-42.
- Background: PubMed 11028655Alamoudi OS. Hypomagnesaemia in chronic, stable asthmatics: prevalence, correlation with severity and hospitalization. Eur Respir J. 2000 Sep;16(3):427-31. doi: 10.1034/j.1399-3003.2000.016003427.x.
- Background: PubMed 14979636Bede O, Suranyi A, Pinter K, Szlavik M, Gyurkovits K. Urinary magnesium excretion in asthmatic children receiving magnesium supplementation: a randomized, placebo-controlled, double-blind study. Magnes Res. 2003 Dec;16(4):262-70.
- Background: PubMed 16254259Aziz 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.
- Background: PubMed 18043278Rowe BH, Camargo CA Jr. The role of magnesium sulfate in the acute and chronic management of asthma. Curr Opin Pulm Med. 2008 Jan;14(1):70-6. doi: 10.1097/MCP.0b013e3282f19867.
- Background: PubMed 15726901Nasulewicz A, Zimowska W, Bayle D, Dzimira S, Madej J, Rayssiguier Y, Opolski A, Mazur A. Changes in gene expression in the lungs of Mg-deficient mice are related to an inflammatory process. Magnes Res. 2004 Dec;17(4):259-63.
- Background: PubMed 16788707Gontijo-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.
- Background: PubMed 14519140Fogarty A, Lewis SA, Scrivener SL, Antoniak M, Pacey S, Pringle M, Britton J. Oral magnesium and vitamin C supplements in asthma: a parallel group randomized placebo-controlled trial. Clin Exp Allergy. 2003 Oct;33(10):1355-9. doi: 10.1046/j.1365-2222.2003.01777.x.
- Background: PubMed 9387944Hill J, Micklewright A, Lewis S, Britton J. Investigation of the effect of short-term change in dietary magnesium intake in asthma. Eur Respir J. 1997 Oct;10(10):2225-9. doi: 10.1183/09031936.97.10102225.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Dahl, Professor principal investigator
Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium supplement (magnesium hydroxide/ -oxide) in people with COPD, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01118936, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.