In this study 34 chronically transfused Beta Thalassemia patients who are receiving Iron chelators will included. Patients whose iron chelators change during the study; Patients whose pattern of blood infusion changes during the study; Pregnant women; Patients with renal failure and creatinine clearance (GFR) lower than 30 ml/min will excluded from the study. Patients will take 200 micrograms of selenium supplement daily for one month. Blood sample will be taken from patients before intervention and afterwards at the end of the month. Serum level of ferritin, Iron, Glutation peroxidase and selenium will be measured at baseline and after a month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021226998N3
Registration date:2017-06-01, 1396/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Saba Ghaffary
Name of organization / entity
Faculty of Pharmacy, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33266042
Email address
ghaffarys@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Ghazi hematology and oncology research center
Expected recruitment start date
2017-01-24, 1395/11/05
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of oral administration of selenium on serum ferritin level and serum iron concentration in patients with Beta Thalassemia major
Public title
Effects of oral administration of selenium on serum ferritin level and serum iron concentration in patients with Beta Thalassemia major
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Beta Thalassemia major
Exclusion criteria: Patients whose iron chelators change during the study; Patients whose pattern of blood infusion changes during the study; Pregnant women; Patients with renal failure and creatinine clearance (GFR) lower than 30 ml/min
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Street address
Daneshgah street, Daneshgah square
City
Tabriz
Postal code
Approval date
2017-04-10, 1396/01/21
Ethics committee reference number
IR.TBZMED.REC.1396.13
Health conditions studied
1
Description of health condition studied
BetaThalassemia major
ICD-10 code
17
ICD-10 code description
ناهنچاری های مادرزادی، اختلال در شکل گیری و ناهنجاری های کروموزومی