Evaluation the Effect of Silymarin on Serum Ferritin and Iron Level in Comparison with Placebo in β-thalassemia Patients undergoing Iron Chelation Therapy
A randomized, double-blind and crossover trial was performed on 70 beta thalassemia patients at the Thalassemia Research Center in Mazandaran University of Medical Sciences. The aim of this study was determination of silymarin effects on serum ferritin and iron levels in comparison with placebo in β-thalassemia patients undergoing iron chelation therapy. This study had been designed in three phases. During the first phase, patients were received silymarin tablet (420 mg - three times a day) or placebo tablet (three times a day) for 12-weeks. Phase 2 was a washout phase during 2-weeks. During phase 3, patients who randomly were assigned to receive silymarin were changed to receive placebo. Also, patients randomly were assigned to receive placebo during phase 1 were changed to receive silymarin. Serum iron, ferritin, and TIBC were measured immediately before and after each period. Change of treatment regimen was exclusion criteria during study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101211819N2
Registration date:2016-04-10, 1395/01/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-10, 1395/01/22
Registrant information
Name
Hadi Darvishi Khezri
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1213 3857
Email address
hadidarvishi@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
7 km of sea road, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Silymarin on Serum Ferritin and Iron Level in Comparison with Placebo in β-thalassemia Patients undergoing Iron Chelation Therapy
Public title
Effect of Silymarin on Serum Ferritin and Iron Level in β-thalassemia Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with beta thalassemia major; History of iron chelation therapy for at least 2 years; Having relatively constant average dose of iron chelation during 3 months ago; Ferritin up to 1000 μg/L
Exclusion criteria: Change therapeutic regimen with iron chelation during the study (6 months)
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
Street address
Vice chancellor for research, Moallem Square, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
City
Sari
Postal code
Approval date
2014-10-23, 1393/08/01
Ethics committee reference number
1126
Health conditions studied
1
Description of health condition studied
Thalassaemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Serum Iron Level
Timepoint
1-Before the first phase 2- After the washout period (after 2 weeks of the end of the first phase) 3- After the third phase (after 26 weeks)
Method of measurement
Serum Iron was measured by spectrophotometry
2
Description
Serum Ferritin Level
Timepoint
1-Before the first phase 2- After the washout period (after 2 weeks of the end of the first phase) 3- After the third phase (after 26 weeks)
Method of measurement
Serum ferritin was measured by ELISA test
Secondary outcomes
1
Description
Incidence of adverse drug reactions
Timepoint
1-Before the first phase 2- After the washout period (after 2 weeks of the end of the first phase) 3- After the third phase (after 26 weeks)
Method of measurement
Data collection form
Intervention groups
1
Description
Patients in the intervention group received 420 milligrams of silymarin tablets, three times per day.
Category
Treatment - Drugs
2
Description
Patients in the control group received placebo tablets, three times per day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia Research Center, Bu-Ali Hospital, Sari, Mazandaran, Iran
Full name of responsible person
Hadi Darvishi Khezri
Street address
Thalassemia Research Center, Bu-Ali Hospital, Sari, Mazandaran, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor for research, Moallem Square, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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
7 km of sea road, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
Full name of responsible person
Hadi Darvishi Khezri
Position
Student in PhD by research
Other areas of specialty/work
Street address
Thalassemia Research Center, Bu-Ali Hospital, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 11 3334 7837
Fax
Email
Hadidarvishi87@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
7 km of sea road, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
Full name of responsible person
Ebrahim Salehifar
Position
Professor of clinical pharmacology
Other areas of specialty/work
Street address
7 km of sea road, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 911 154 4526
Fax
Email
salehifar@mazumz.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
7 km of sea road, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
Full name of responsible person
Hadi Darvishi Khezri
Position
Student in PhD by research
Other areas of specialty/work
Street address
Thalassemia Research Center, Bu-Ali Hospital, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 91133347837
Fax
Email
Hadidarvishi87@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)