study target: Investigating the effect of oral desensitization in patients with acute allergy to cow milk based on Prick skin test study design: clinical trial with no control group, before after compare Main inclusion criteria: Patients with sever IgE mediated hypersensitivity reactions to Cow's Milk which weren't improved over 2 years of age main exclusion criteria: Uncontrolled asthma; Cardiovascular disease or other significant systemic disease; Patients having poor compliance sample size: at least18 person intervention: oral desensitization to cow milk duration of intervention: in 6 month, weekly primary outcomes: Prik skin test, Anti milk IgE
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013080814305N1
Registration date:2014-02-12, 1392/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-12, 1392/11/23
Registrant information
Name
ِDelara Babaie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
dbabaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Mofid children's Hospital, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-05-01, 1392/02/11
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of oral desensitization in patients with acute alergy to cow milk based on Prik skin test
Public title
Investigating the effect of oral desensitization in patients with acute alergy to cow milk based on Prik skin test
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Patients with sever IgE mediated hypersensitivity reactions to Cow's Milk which weren't improved over 3 years of age; Immediate reaction in open oral cow's milk challange;• Diet free from milk and milk products
Exclusion Criteria:
Uncontrolled asthma; Cardiovascular disease or other significant systemic disease; Patients having poor compliance
Age
From 3 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mofid research excellence center
Street address
Shariati, Mofid children's hospital
City
Tehran
Postal code
Approval date
2014-12-24, 1393/10/03
Ethics committee reference number
1392-1-119-1186
Health conditions studied
1
Description of health condition studied
cow's Milk allergy
ICD-10 code
T78.0
ICD-10 code description
Anaphylactic shock due to adverse food reaction
Primary outcomes
1
Description
Prik skin test
Timepoint
begining of study, month 6
Method of measurement
observation of redness of aleren contact areaa, itching
2
Description
Anti cow's milk IgE
Timepoint
begining of study, month 6
Method of measurement
titration of IgE, Eliza
Secondary outcomes
empty
Intervention groups
1
Description
Fifteen children over 3 year with history of anaphylaxis to cow’s milk, positive skin prick test ( SPT), and positive oral food challenge were recruited. Skin prick test with Milk extract, full dilution and different dilutions of milk, depends on patient’s reaction was performed for all the patients. The dilution of milk which induced 3-5 mm of wheal was selected as a stating dilution. Then it started form 2 drop of the dilution and increased according the protocol. The dose was increased weekly to achieve an intake of 120 mL in approximately 4 months. All doses were administered under medical supervision in a clinical setting. After receiving the dose, children were carefully assessed for positive reactions. In the cases of anaphylaxis the dose returned to the last tolerated dose for one week, then it was increased slower
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's Hospital
Full name of responsible person
Delara Babaie
Street address
Dep. of allergy , Mofid children's Hospital , Shariati St.
City
Tehran
2
Recruitment center
Name of recruitment center
Rasool hospital
Full name of responsible person
Morteza fallahpour
Street address
Dep. of allergy and clinical immunology, rasool hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mofid research excellence center
Full name of responsible person
Fatemeh Gorji
Street address
Mofid children's hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mofid research excellence center
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Delara Babaie
Position
Assistant professor of Allergy and Clinical Immunology
Other areas of specialty/work
Street address
Dep. of allergy, Mofid Children's Hospital, Shaariati, St.
City
Tehran
Postal code
Phone
+98 21 2222 7021
Fax
+98 21 2222 7033
Email
dbabaie@ sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Delara Babaie
Position
Assistant professor of Allergy and Clinical Immunology
Other areas of specialty/work
Street address
Dep. od Allergy, Mofid children's hospital, Shariati St.
City
Tehran
Postal code
Phone
+98 21 2222 7021
Fax
+98 21 2222 7033
Email
delara77@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran university of Medical Sciences
Full name of responsible person
Morteza fallahpour
Position
Fellow of Allergy and Clinical Immunology
Other areas of specialty/work
Street address
Dep. of Allergy,Rasool Akram Hospital, Niayesh St., Sattarkhan
City
Tehran
Postal code
Phone
+98 21 6655 4933
Fax
+98 21 6655 4933
Email
fallahpour.morteza@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)