To compare the mean serum ferritin level with oral versus injectable iron chelation therapy in patients with transfusion dependent thalassemia.
Design
A single center, open-labelled, randomized controlled trial. Children in the intervension group will be given oral iron chelation therapy i.e. daily Deferiprone at a dose of 75mg/kg/day in two to three divided doses for a period of 6-months. In the control group, children will be given injectable iron chelation therapy i.e. single dose of deferoxamine 4 mmol, 6 days a week for a duration of 6-months). Sample size will be 50 children (25 in each gropu) as per inclusion and exclusion criteria.
Settings and conduct
This open labelled trial will be conducted at The Department of Pediatric Medicine, DHQ Teaching Hospital, Dera Ghazi Khan, Pakistan
Participants/Inclusion and exclusion criteria
Inclusion criteria will be children of both genders and age >1 up to 15 years presenting with beta thalassemia major.
Exclusion criteria will be children already taking trial treatment, or liver failure (ALT & AST >50IU), anemia (hemoglobin level <10 g/dl) or those who will lose during the follow ups.
Intervention groups
In the intervension group will be given oral iron chelation therapy i.e. daily Deferiprone at a dose of 75mg/kg/day in two to three divided doses for a period of 6-months.
Control group: Children will be given injectable iron chelation therapy i.e. single dose of deferoxamine 4 mmol (225 mg) daily, 6-days a week, for a period of 6-months.
Main outcome variables
Serum ferritin will be assessed at baseline and after 6 months of therapy in terms of ng/ml and change in serum ferritin level will be calculated as difference in serum ferritin level obtained at two follow-up visits.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221231056999N2
Registration date:2023-07-25, 1402/05/03
Registration timing:prospective
Last update:2023-07-25, 1402/05/03
Update count:0
Registration date
2023-07-25, 1402/05/03
Registrant information
Name
M Aamir
Name of organization / entity
RESnTEC, Institute of Research
Country
Pakistan
Phone
+92 321 6801143
Email address
aamir@resntec.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-02-28, 1402/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Oral versus Injectable Iron Chelation Therapy in Reducing Serum Ferritin Levels in Patients with Transfusion Dependent Thalassemia
Public title
Comparison of Oral versus Injectable Iron Chelation Therapy in Reducing Serum Ferritin Levels in Patients with Transfusion Dependent Thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presenting with beta thalassemia major (defined as group of hereditary disorders characterized by a genetic deficiency in the synthesis of beta-globin chains in blood causes severe, transfusion-dependent anemia).
Patients who are transfusions dependent with serum ferritin level >2000 ng/ml.
Exclusion criteria:
Children already taking trial treatment (as per medical record).
Children with liver failure (ALT & AST >50IU).
Children having anemia (hemoglobin level <10 g/dl)
Children who will lose during follow ups.
Parents/Guardian refused the participation of their child.
Stoppage of medicine due to side effects/compliance.
Age
From 1 year old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Children will be randomly divided in two groups by using random number table that will be generated by using Microsoft Excel
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
Institutional Ethical Committee
Street address
Jampur Road
City
Dera Ghazi Khan
Postal code
32200
Approval date
2023-04-20, 1402/01/31
Ethics committee reference number
45-IEC-2032
Health conditions studied
1
Description of health condition studied
Beta thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Serum ferritin level
Timepoint
Assessed at baseline and after 6 months of therapy
Method of measurement
Blood sample will be taken by using 3cc disposable syringe and sent to the laboratory of the hospital for assessment of serum ferritin level using standard laboratory protocols.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children will be given oral iron chelation therapy i.e. daily Deferiprone at a dose of 75mg/kg/day in two to three divided doses, for a period of 6-months.
Category
Treatment - Drugs
2
Description
Control group: Children will be given injectable iron chelation therapy i.e. single dose of deferoxamine 4 mmol (225 mg) daily, 6-days a week, for a period of 6-months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatric Medicine, DHQ Teaching Hospital, Dera Ghazi Khan
Full name of responsible person
Dr. Fatima Rafique
Street address
Jampur Road
City
Dera Ghazi Khan
Postal code
32200
Phone
+92 335 0999989
Email
aamir@resntec.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
DHQ Teaching Hospital
Full name of responsible person
Dr. Fatima Rafique
Street address
Jampur Road
City
Dera Ghazi Khan
Postal code
32200
Phone
+92 335 0999989
Email
aamir@resntec.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
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
RESnTEC, Institute of Research
Full name of responsible person
M. Aamir
Position
Research Consultant
Latest degree
Bachelor
Other areas of specialty/work
Research Consultation
Street address
Street No.1
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 321 6801143
Email
aamir@resntec.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
RESnTEC, Institute of Research
Full name of responsible person
M. Aamir
Position
Punjab
Latest degree
Bachelor
Other areas of specialty/work
Research Consultancy
Street address
Street No.1
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 321 6801143
Email
aamir@resntec.com
Person responsible for updating data
Contact
Name of organization / entity
RESnTEC, Institute of Research
Full name of responsible person
M. Aamir
Position
Research Consultant
Latest degree
Bachelor
Other areas of specialty/work
Research Consultancy
Street address
Street No.1
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 321 6801143
Email
aamir@resntec.com
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
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available