Purpose: using of vitamin D more than the usual dose can be effective in prevention or incidence of respiratory infections in children. There is no consensus on the antimicrobial mechanisms of vitamin D But some researchers have suggested that vitamin D can be effective through increased production of some proteins involved in innate immunity.This study aimed to evaluate the effect of single dose prescription of vitamin D in the course of respiratory infections in children hospitalized in Ardabil Bu Ali hospital and its relationship with blood levels of the vitamin D active forms. Design and implementation : In this study , 80 children aged 6 months to 6 years with bacterial pneumonia hospitalized in Bu Ali hospital divided into two groups randomly. Participants included the main inclusion and exclusion criteria: bacterial pneumonia, the age of six months to six years, hospitalization in the Bu Ali hospital , parental consent. Exclusion criteria included: Rickets, other associated infectious diseases such as meningitis, active and hidden tuberculosis, viral pneumonia , consumption of vitamin D with high-dose in the last three months, severe malnutrition and underlying diseases such as cystic fibrosis and metabolic syndromes. Intervention: first group recieved 100000 IU of oral single dose of vitamin D and second group as control were selected randomly and received sweet almond oil as a placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052617843N2
Registration date:2014-07-26, 1393/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-26, 1393/05/04
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
2012-08-22, 1391/06/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of vitamin D in pneumonia treatment in hospitalized children, double-blind randomized clinical trial
Public title
The effect of vitamin D in hospitalized children for respiratory infection treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged six months to six years; Hospitalization in Bu Ali hospital with bacterial pneumonia; parental consent.
Exclusion criteria: Rickets; along with other infectious diseases such as meningitis; tuberculosis; viral pneumonia; the use of high-dose vitamin D in the last three months; severe malnutrition and diseases such as cystic fibrosis and metabolic syndrome.
Age
From 6 months old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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, Daneshgah Street, Ardabil University of Medical Sciences.
City
Ardabil
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
9190
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J12
ICD-10 code description
Viral pneumonia, not elsewhere classified
Primary outcomes
1
Description
Disease Improvment.
Timepoint
12 weeks.
Method of measurement
Chest radiography.
Secondary outcomes
1
Description
Interferon gamma
Timepoint
10 days.
Method of measurement
Folin–Ciocalteu reagent
2
Description
IL-6
Timepoint
10 days.
Method of measurement
ELISA metod.
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
Bo Ali Hospital
Full name of responsible person
Dr adel ahadi
Street address
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
Professor of Pediatrics
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 Asefe Mortazavi
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)