The effectiveness of synbiotic on the severity of atopic dermatitis in children 1 to 24 months
The effectiveness of viamin D on the severity of atopic dermatitis in children 1 to 24 months
Comparison of the efficacy of synbiotic and vitamin D on the severity of atopic dermatitis in 1 to 24 month old children
Design
The clinical trial included two intervention groups and one control, randomized, double blind
Settings and conduct
80 patients who referd to the Haishamtahi Pediatric Clinic and have inclusion criteria are selected. All patients are examined by the physician and their severity is recorded according to SCORAD criteria. The samples are randomly divided into three groups. All patients receive routine therapies. The first group also received Padilact drops and the second group received Vitamin D. The third group only receives routine treatments for two months. After the intervention, all patients are re-examined by the same physician and the SCORAD criteria for them are calculated and recorded, and the results are compared. The examiner is unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria;
Being 1-24 month of age
Absence of any other chronic disease
Having used no immunosuppressive medicines, corticosteroids and antibiotics for one week prior of the study
Mother's willingness
Exclusion criteria;
Infectious disease
receive immunosuppressive medicines, corticosteroids and antibiotics
Mother's unwillingness
Intervention groups
The synbiotic group that receives 5 podiatric drops daily in addition to routine treatments
The vitamin D group, which receives 1000 units of vitamin D per day in addition to routine treatments
The control group receives only routine therapies including topical corticosteroids, antihistamines, and the like
Main outcome variables
Score of Atopic Dermatitis according to SCORAD
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180626040248N1
Registration date:2018-09-22, 1397/06/31
Registration timing:retrospective
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
fatemeh shamabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4441 0325
Email address
fatemeh.shamabadi@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
1988-07-11, 1367/04/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of Synbiotic and Vitamin D on the Severity of Atopic Dermatitis in 1 to 24 Months Old Children
Public title
Effectiveness of Synbiotic and Vitamin D in Atopic Dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being 1-24 month of age
Absence of any other chronic disease
Having used no immunosuppressive medicines, corticosteroids and antibiotics for one week prior of the study
Mother's willingness
Exclusion criteria:
Infectious disease
Receive immunosuppressive medicines, corticosteroids and antibiotics
Mother's unwillingness
Age
From 1 month old to 24 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After checking the inclusion and excclusion critria, patients are randomly (six blocks) divided into three groups which are defined by the statistic consultant by using random allocatin software
Blinding (investigator's opinion)
Triple blinded
Blinding description
The parents of patients are not known to be in the intervention or control group
The examiner, who evaluates the severity of the illness, is unaware of the type of treatment that the patient received and their group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Intervention group1: In this group, patients receive 5 drops of pedilact daily for two months in addition to routine treatments . pedilact is a synbiotic ( prebiotic + probiotic)
Category
Treatment - Drugs
2
Description
Intervention group2: In this group, patients receive 1,000 units of vitamin D per day for two month in addition to routine treatments.(1cc of drop vitamin D 1000iu)
Category
Treatment - Drugs
3
Description
Control group: In this group, patients receive routine treatments including topical corticosteroids, moisturizing agents, antihistamines, and ext.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatieh hospital
Full name of responsible person
Fatemeh Shamabadi
Street address
Asadabadi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1600
Email
fatemeh.shamabadi@medsab.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Shohadaye hasteie Blvd., Tohid town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
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
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Shamabadi
Position
medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tohid town
City
Sabzevar
Province
Razavi Khorasan
Postal code
96179-56333
Phone
+98 51 4441 0325
Email
fatemeh.shamabadi@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mitra Aldaghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Asadabadi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1600
Email
mitra.aldaghi@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fatemeh Shamabadi
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tohid Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
96179-56333
Phone
+98 51 4441 0325
Fax
Email
fatemeh.shamabadi@medsab.ac.ir
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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