The Effects of Vitamin E And Folic Acid on The improvement of acute hemolysis Due of deficient G6PD on the children refer to the 17th Shahrivar hospital in Rasht, 2014.
The aim of this study is to assess the Efficacy of Vitamin E And Folic Acid on the improvement of acute hemolysis Due of deficient G6PD on the children refer to the 17th Shahrivar hospital in Rasht, 2014.patients are children aged 1-14 years which reffered to 17 shahrivar hospital during 2014-2015. G6PD deficiencient children with hemolytic anemia consequent to acute phase will be included.120 patients will be entered in 4 parallel groups with the same sample size. first group(100 mg vitamin E for children aged 1-2 years, 200 mg for children aged 2-3 years, 300 mg for children aged 3-4 years and 400 mg for children aged more than 4 years) second group (daily acid foic ,200 mg for children aged 1-2 years and 5 mg for children aged more than 2 years) third group used vitamin E and folicacid for 2 weeks forth group recieved no drug.(control group) the level of hemoglobin and the percentage of reticoluocyte will be measured before intervention and 2 weeks after the initiation of intervention. if patients need blood transfusion, the volume of infused blood and the number of infusions will be registered for each patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102019541N1
Registration date:2014-11-04, 1393/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-04, 1393/08/13
Registrant information
Name
Adel Baghersalimi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 6101
Email address
baghersalimi498@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Deputy of Research of Guilan University Of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Vitamin E And Folic Acid on The improvement of acute hemolysis Due of deficient G6PD on the children refer to the 17th Shahrivar hospital in Rasht, 2014.
Public title
The Effects of Vitamin E And Folic Acid on The improvement of acute hemolysis Due of deficient G6PD on the children refer to the 17th Shahrivar hospital in Rasht, 2014.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age: 1-14 yeaers; G6PD deficient children; acutephase hemolysis; no use of vitamine E or folic acid during past 1 months.
exclusion criteria : no referal for followup labaratory examinations; death before the end of the study; hemolysis consequent to other causes exept G6PD deiciency
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Deputy of Research of Guilan University of Medical Sciences
Street address
Gaz Square
City
Rasht
Postal code
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
1930309902
Health conditions studied
1
Description of health condition studied
Glucose 6 Phosphate Dehydrogenase Deficiency
ICD-10 code
D55.0
ICD-10 code description
Anaemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency
Primary outcomes
1
Description
The level of Hemoglobine
Timepoint
Before Intervention and 2 Weeks after the initiation of intervention
Method of measurement
Based on gram per deciliter with the complete bloodcells count examination
Secondary outcomes
1
Description
assessing the level of reticoluocyte
Timepoint
before interventions and 2 weeks after the initiation of intervention
Method of measurement
the percentage of reticoluocytes derived from complete bloodcells count
Intervention groups
1
Description
first group(100 mg vitamin E for children aged 1-2 years, 200 mg for children aged 2-3 years, 300 mg for children aged 3-4 years and 400 mg for children aged more than 4 years) 2 weeks, oral
Category
Treatment - Drugs
2
Description
Third group 100 mg vitamin E for children aged 1-2 years, 200 mg for children aged 2-3 years, 300 mg for children aged 3-4 years and 400 mg for children aged more than 4 years and 2mg folic acid daily for children aged 1-2 years
and 5 mg folic acid daily for children aged more than 2 years. 2 Weeks oral
Category
Treatment - Drugs
3
Description
Second group
2mg folic acid daily for children aged 1-2 years
and 5 mg folic acid daily for children aged more than 2 years. 2 Weeks oral
Category
Treatment - Drugs
4
Description
control group: no treatment will be adminstered
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
17 shahrivar hospital
Full name of responsible person
Dr Adel Baghersalimi
Street address
17 Shahrivar Hospital, Shahid Siadati Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
TeDdeputy of Research of Guilan University of Medical Sciences
Full name of responsible person
Dr Abtin Heidarzadeh
Street address
Gaz Square
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
TeDdeputy of Research of Guilan 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
Guilan University Of Medical Sciences
Full name of responsible person
Dr Adel Baghersalimi
Position
Peciaric Hematologist and Oncologist Assistant Professor
Other areas of specialty/work
Street address
17 Shahrivar Hospital , Hematology Ward
City
Rasht
Postal code
Phone
+98 13 3332 6101
Fax
Email
baghersalimi498@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Adel Baghersalimi
Position
Pediatric Hematologist Oncologist Assistant Professor
Other areas of specialty/work
Street address
17 Shahrivar Hospital
City
Rasht
Postal code
Phone
+98 13 3332 6101
Fax
Email
baghersalimi498@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical sciences
Full name of responsible person
Dr Sharareh Zarezadeh
Position
medical resident
Other areas of specialty/work
Street address
17 Shahrivar Hospital, Shahid Siadati Square
City
Rasht
Postal code
Phone
+98 33326101
Fax
Email
dr.zarezadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)