Aim of this study is evaluation of the effect of folate supplement on red blood cells indices and sense of well being of children suffering from minor thalassemia. Inclusion criteria: children 5-15 years of age with thalassemia. Exclusion criteria: iron deficiency anemia and thalassemia minor, underlying disease, lack of compliance to medication. This study is clinical trials and double blind.290 patients with minor thalassemia will enter this study. We check all patients for complete blood cells and feritin and red blood cells and Red blood cell distribution width. We will divide patients in two groups. We prescribe Folic acid daily in morning fasting for six months in intervention group. We prescribe placebo daily in morning fasting for six months in control group. We check complete blood cells and feritin and red blood cells and Red blood cell distribution width after six months. We check well being of children for Psychological testing in first and end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051520258N48
Registration date:2017-05-30, 1396/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-30, 1396/03/09
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Arak University of Medical Sciences
Expected recruitment start date
2017-03-18, 1395/12/28
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of folate supplement on red blood cells indices and the sense of well being of children suffering from minor thalassemia
Public title
Effect of folate supplement on sense of well being of children suffering from minor thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children 5-15 years of age with thalassemia
Exclusion criteria: iron deficiency anemia and thalassemia minor, underlying disease, lack of compliance to medication
Age
From 5 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
290
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-03-15, 1395/12/25
Ethics committee reference number
IR.ARAKMU.REC.1395.399
Health conditions studied
1
Description of health condition studied
minor thalassemia
ICD-10 code
D56.9
ICD-10 code description
Thalassaemia, unspecified
Primary outcomes
1
Description
well being of children
Timepoint
start and six months after study
Method of measurement
Psychological testing
2
Description
complete blood cells
Timepoint
first and 6 months after
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We prescribe 1 milligram Folic acid daily in morning fasting for six months in intervention group.
Category
Treatment - Drugs
2
Description
control group:We prescribe placebo daily in morning fasting for six months in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr fatemeh dorreh
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences