Effect of oral vitamin D supplementation on serum markers of oxidative stress and antioxidant in asthmatic children and its comparison with control group.
Despite numerous publications on the relationship between vitamin D and immune system, yet the precise role of vitamin D in asthma from clinical viewpoint is contraversive .The purpose of randomized, double-blind placebo-controlled study, was to determine the levels of oxidative stress and antioxidant markers levels in asthmatic children after oral vitamin D prescription and its comparison with the control group. Design and implementation: In this study, 60 children with asthma hospitalization randomly divided into two groups of 30 subjects. Interventions: One group received a single oral dose of 100,000 IU of vitamin D and the second group that its randomly selected, received sweet almond oil as placebo. Inclusion criteria: asthma,Ardabil Bouali Hospital admission. Exclusion criteria: pneumonia, Rickets, the use of high-dose vitamin D in the last three months, severe malnutrition and diseases such as cystic fibrosis and metabolic syndrome. the serum level of 25 (OH) vitamin D will be measured prior to intervention and at the end of study (10 days). serum glutathion and total antioxidant capacity will be measured at the end of study ( after 10 days of treatment). The effect of Vitamin D supplementation on clinical signs and symptoms of asthma will be evaluated as primary outcome measure. the serum level of oxidative stress and antioxidant makers will be evaluated as second primary outcome measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014053117843N3
Registration date:2014-08-04, 1393/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Adel Ahadi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1773 1210
Email address
a.ahadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral vitamin D supplementation on serum markers of oxidative stress and antioxidant in asthmatic children and its comparison with control group.
Public title
Vitamin D supplementation and its effect on markers of oxidative stress and antioxidant in asthmatic children.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: asthma; Bouali Hospital admission.
Exclusion criteria: pneumonia; Rickets; the use of high-dose vitamin D in the last three months; severe malnutrition; diseases such as cystic fibrosis.
Age
From 4 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences.
Street address
Ardabil, University Ave, Ardabil University of Medical Sciences.
City
Ardabil.
Postal code
Approval date
2013-09-15, 1392/06/24
Ethics committee reference number
9220
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Clinical improvement
Timepoint
8 weeks
Method of measurement
Spirometry
Secondary outcomes
1
Description
Glutathione
Timepoint
8 weeks
Method of measurement
Folin–Ciocalteu reagent
2
Description
serum Total antioxidant capacity (TOC)
Timepoint
10 days
Method of measurement
Spectrophotometery
Intervention groups
1
Description
In this study to intervention group, prescribed vitamin D vial 100000 IU, orally, once.
Category
Treatment - Drugs
2
Description
In this study to placebo group, prescribed Sweet oil vial, orally, once.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Hospital
Full name of responsible person
Dr adel ahadi
Street address
Ardabil, Varzesh square, Bouali Hospital.
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Hadi Piri dogahe
Street address
Ardabil, Daneshgah Street, Ardabil University of Medical Sciences.
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
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
Ardabil University of Medical Sciences.
Full name of responsible person
Dr Adel Ahadi
Position
Ardabil, Boali Hospital.
Other areas of specialty/work
Street address
Ardabil, Boali Hospital
City
Ardabil
Postal code
Phone
+98 914 451 5486
Fax
Email
a.ahadi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boali Hospital
Full name of responsible person
Dr Shahab Bohlooli
Position
Pharmacology Phd
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1551 0052
Fax
Email
shahab.bohlooli@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
dr Leila Katebi
Position
pediatric assistant
Other areas of specialty/work
Street address
City
Ardabil
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)