The aim of this clinical trial is to investigate the effect of magnesium supplements on asthma control.
Design
This is a clinical trial study of patients with severe asthma referring to the specialized lung clinic of Imam Khomeini Hospital in Sari, from October 2016 to October 2018.
Settings and conduct
This study is a double-blind clinical trial that will be performed on patients aged 18-60 years with asthma referring to the specialized lung clinic of Imam Khomeini Hospital in Sari. The randomization method in this randomized study is easy to use, using a random number table.
The study included two groups of patients receiving magnesium supplementation and a control group that receives a placebo.
The supplement and the placebo are similar and each one receives a code and the patient and distributor of the drug do not know the type of drug and their distribution.
Participants/Inclusion and exclusion criteria
Exclusion criteria: severe asthma, use of oral corticosteroids and diuretics, renal failure, and so on.
Intervention groups
20 mg of magnesium supplement daily and up to 8 weeks for case group.
20 mg placebo daily and up to 8 weeks for the control group.
Main outcome variables
changes in FEV1 / FEC, FVC, FEV1 parameters during study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170827035935N2
Registration date:2018-02-10, 1396/11/21
Registration timing:registered_while_recruiting
Last update:2018-02-10, 1396/11/21
Update count:0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Babak Mahmoodi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 937 114 3879
Email address
h.jafarpour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of the study of the effect of magnesium supplementation on asthma
Public title
The effect of magnesium in controlling asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with asthma
Exclusion criteria:
Use of oral corticosteroids
Use Diuretics
Renal failure
Congestive heart failure
Use of magnesium supplement in the past quarter
History of using cigarettes
Pregnancy
The decision to have a pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this randomized study is easy randomization. Patients will be placed in two groups of control (non-supplement magnesium) and the case group (magnesium supplements recipient) using a randomized table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not be aware of any kind of medication (magnesium supplement or placebo), and the investigator will not know whether each patient receives medication or placebo. The placebo is completely white in the form of pills. It is a homogeneous with complementary magnesium supplement that is provided by the Faculty of Pharmacy of Mazandaran University of Medical Sciences.
Magnesium supplement is purchased in the number of intervention group and code A is written by the clinical pharmacist on the pill.
The placebo is provided for the control group and code B is written by the pharmacist of the study on the container.
The patient and researcher responsible for distributing the medicine are not aware of the type of medicine and their distribution.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of research and technology, Moalem Sq
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2017-08-19, 1396/05/28
Ethics committee reference number
IR.MAZUMS.IMAMHOSIPTAL.REC.96.2886
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.9,J46
ICD-10 code description
Asthma, unspecified, Acute severe asthma
Primary outcomes
1
Description
Severity of asthma
Timepoint
At the beginning of the study (before the intervention) and at weeks 4, 8 and 12 after the intervention
Method of measurement
PEFR measurements by peak flow meter
2
Description
FEV1/FVC
Timepoint
Before and immediately after the intervention
Method of measurement
Spirometry
3
Description
The number of asthma attacks
Timepoint
At the beginning of the study (before the intervention) and at weeks 4, 8 and 12 after the intervention
Method of measurement
Ask the patient
4
Description
ACT-Score
Timepoint
At the beginning of the study (before the intervention) and at weeks 4, 8 and 12 after the intervention
Method of measurement
ACT questionnaire
5
Description
FEV1
Timepoint
Before and immediately after the intervention
Method of measurement
Spirometry
6
Description
FVC
Timepoint
Before and immediately after the intervention
Method of measurement
Spirometry
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Magnesium Supplement with Brand Magne B6, product of Sanofi Aventis Pharmaceutical Factory, containing 470 mg of lactate magnesium, equivalent to 48 mg of magnesium, begins twice a day and will be used as a preservative for up to 8 weeks on a daily basis.
Category
Treatment - Drugs
2
Description
Control group: The Placebo made by pharmaceutical faculty of the Mazandaran University of Medical Sciences will be used twice a day and as a preservative for up to 8 weeks on a daily basis.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Clinic of Imam Khomeini Hospital
Full name of responsible person
Babak Mahmoodi
Street address
Imam Khomeini Educational Center, Razi St.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 1700
Email
hamed.jafarpour7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Science
Full name of responsible person
Majid Saeidi
Street address
Vice chancellor for research, Mazandaran University of Medical Science, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3326 1249
Email
hamed.jafarpour7@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Science
Full name of responsible person
Dr. Ali Sharif Pour
Position
Asociated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Departmnt, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4864
Fax
Email
hamed.jafarpour7@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Babak Mahmoodi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Payambar Azam Campus, Km 17 on Farah Abad road
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4864
Fax
Email
hamed.jafarpour7@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Babak Mahmoodi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Payambar Azam Campus, Km 17 on Farah Abad road
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4864
Fax
Email
hamed.jafarpour7@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available