Asthma is the most common chronic medical condition that leads to serious health and economic consequences. There is evidence that high intake of magnesium is effective on pulmonary function, and reduce sensitivity of bronchial. Most assessments of asthma based on symptoms and lung function testing , Quality of life is a concept that has recently been considered in the management of asthma. The purpose of this study was to evaluate the effect of oral magnesium supplementation on lung function, quality of life, asthma control and inflammatory factors in adult patients with asthma .
Methods: In this double- blind clinical trial, 100 patients (53 male, 47 female), 19-55 years old with asthma were randomly assigned to two groups. Group supplemented daily received 2 capsuls 150 mg magnesium citrate and placebo groups received 2 capsules contain lactose, in addition to standard asthma treatment for 2 months. Serum magnesium levels, quality of life, asthma control, IL-17 and spirometric parameters were measured at the beginning and end of the study. IL-17 levels were determined by ELISA.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2012102811285N1
Registration date:2015-05-18, 1394/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-18, 1394/02/28
Registrant information
Name
Narges Fathi
Name of organization / entity
Jundishapur university
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 7168
Email address
fathi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University
Expected recruitment start date
2012-05-31, 1391/03/11
Expected recruitment end date
2012-10-01, 1391/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral magnesium supplement on lung function in patients with asthma
Public title
Clinical trial on effect of oral magnesium supplement on lung function in patients with asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Men and women 19 to 55 years of age who met the Global Initiative for Asthma (GINA) guidelines in 2008, FEV1more than80%, variability FEV1less than 20-30% for mild asthma and FEV1=60-80%, variability FEV1more than 30% for moderate asthmatic; non smoker; who used only beta-agonist or inhaled corticosteroids.
Exclusion criteria: evidence of cardiovascular disease, abnormal kidney function,other lung disease; alcohol abuse; uncontrolled hypertension; pregnancy or breastfeeding; have any change in own diet; current use of theophyline or leukotriene antagonists; any treatment likely to affect magnesium absorption or excretion, including diuretics or calcium containing medications; history of emergency room care or hospitalization for asthma in the last 6 months.
Age
From 19 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Abadan International Unit of Jundishapur University
Street address
Iran, Abadan, Infront of Abadan International University
City
Abadan
Postal code
393/61355
Approval date
2012-05-30, 1391/03/10
Ethics committee reference number
517- ETH
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
x
ICD-10 code description
chronic lower respiratory disease
Primary outcomes
1
Description
Force Vital Capacity
Timepoint
before intervention and two months after the intervention
Method of measurement
based on litter with spirometry
2
Description
Forced expiratory volume in one second
Timepoint
before intervention and two months after the intervention
Method of measurement
based on %liter with spirometry
3
Description
Density of interlukine 17 in blood
Timepoint
before intervention and two months after the intervention
Method of measurement
based on pico grams per milliliter with laboratory kit
4
Description
FEV1/FVC
Timepoint
before intervention and two months after the intervention
Method of measurement
with spirometry
Secondary outcomes
1
Description
magnesium concenteration in serum
Timepoint
before intervention and two months after intervention
Method of measurement
based on mg/dl with laboratory kit
2
Description
level of magnesium intake
Timepoint
three times (two days and one weekend)
Method of measurement
based on mg/d with 24 hours intake for three times
3
Description
levels of quality of life
Timepoint
before intervention and two months after intervention
Method of measurement
numbers of quality of life quationnaire
4
Description
level of asthma control
Timepoint
before intervention and two months after intervention
Method of measurement
numbers of asthma control quationnaire
Intervention groups
1
Description
Intervention group:citrate magnesium,capsules 150 mg oral twice a day for two months
Category
Treatment - Drugs
2
Description
Contol group:placebo,150 mg capsules oral lactose, twice a day for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Lung Clinic of Ahwaz Imam Khomeini Hospital
Full name of responsible person
Doctor Heshmat Alah Tavakol lung Disease Specialist
Street address
Ahwaz, Naderi
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan International Unit Of Ahwaz Jundishapur University
Full name of responsible person
Doctor Nader Saki
Street address
Flat three, Number 119, West Mordad aveniue, Kian Pars, Ahwaz, Iran
City
Ahwaz
Grant name
طرح تحقیقاتی مصوب معاونت پژوهشی دانشگاه علوم پزشکی جندی شاپور
Grant code / Reference number
9109-B
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan International Unit Of Ahwaz Jundishapur University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Abadan International Unit of Ahwaz Jundishapur University
Full name of responsible person
Narges Fathi
Position
Graduate Student Of Nutrition
Other areas of specialty/work
Street address
Abadan,Infront Of International Airport of Abadan, international unit
City
Abadan
Postal code
6155683617
Phone
+98 61 5326 5362
Fax
Email
n.fathi90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University
Full name of responsible person
Seid Ahmad Hosseini
Position
Doctor of Biochemistry
Other areas of specialty/work
Street address
Ahwaz, Pirapezeshki College
City
Ahwaz
Postal code
6155683617
Phone
+98 61 3333 7168
Fax
Email
fathi.n@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Abadan International Unit of Jundishapur University
Full name of responsible person
Narges Fathi
Position
Graduate Student Of Nutrition
Other areas of specialty/work
Street address
Floor3, No119, West Mordad Ave, Kianpars, Ahvaz, Iran
City
Ahwaz
Postal code
6155683617
Phone
+98 61 3336 5730
Fax
Email
n.fathi90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)