Evaluation of the efficacy of N-Acetylcysteine and vitamin E supplementation on oxidative stress status in patients with transfusion-dependent β-thalassemia
Efficacy and safety of N-Acetylcysteine and vitamin E supplementation on oxidative stress status in patients with transfusion-dependent β-thalassemia
Design
In this open-label randomized controlled trial (phase 3), 75 patients with transfusion-dependent & beta -thalassemia will be enrolled. Patients will be randomly allocated in three groups by block randomization method (n=25 in each group).
Settings and conduct
Thalassemia clinic of Dastgheib hospital affiliated to Shiraz University of Medical Sciences. Duration of study is three months. At baseline and at the end of the study, patients will be checked for primary and secondary endpoints
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with transfusion-dependent beta-thalassemia above 18 years old
Treating by at least one or combination of iron chelation therapy agents
Exclusion criteria: No desire to participate in the study
Being positive for hepatitis B, C or HIV
Pregnancy
Presentation of an acute infectious disease
Narcotic addiction
Under treatment with nitroglycerine or other related drugs
Asthma
Known allergy to NAC
Intervention groups
First group NAC group, the second group is the vitamin E group, and the third group is the control group receiving no treatment.
Main outcome variables
Serum TOS and TAC levels at baseline and at the end of the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081207001494N3
Registration date:2019-07-02, 1398/04/11
Registration timing:prospective
Last update:2019-07-02, 1398/04/11
Update count:0
Registration date
2019-07-02, 1398/04/11
Registrant information
Name
sezaneh haghpanah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 2263
Email address
haghpanah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of N-Acetylcysteine and vitamin E supplementation on oxidative stress status in patients with transfusion-dependent β-thalassemia
Public title
N-acetylcysteine and vitamin E in transfusion dependent β-thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with transfusion-dependent beta-thalassemia above 18 years old who were diagnosed by clinical history, and hemoglobin electrophoresis.
Receiving regular blood transfusion (15 cc/kg body weight with interval of 3-4 weeks to maintain hemoglobin levels above 9.5 g/dl)
Treating by at least one or combination of iron chelation therapy agents including deferasirox (DFX), deferiprone (DFP), and deferoxamine (DFO).
Exclusion criteria:
No desire to participate in the study
Being positive for hepatitis B, C or HIV
Pregnancy
Presentation of any acute infectious disease
Narcotic addiction
Under treatment with nitroglycerine or other related drugs
Asthma
Known allergy to NAC
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated in three groups by permuted block randomization method (25 permuted blocks, n=3 in each block).
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
National Ethics Committee in Biomedical research
Street address
13th floor, Block A, Central building of Ministry of Health and Education,-Simay Iran Ave, between South Falamak and Zarafshan, Sharak Ghods (Gharb), Tehran,
City
Shiraz
Province
Fars
Postal code
-----------
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.SUMS.REC.1398.457
Health conditions studied
1
Description of health condition studied
Transfusion dependent beta-thalassemia
ICD-10 code
D56.1
ICD-10 code description
Transfusion dependent beta-thalassemia
Primary outcomes
1
Description
Serum total oxidant status (TOS)
Timepoint
At baseline and at the end of the study
Method of measurement
Blood sampling and using specific kit
2
Description
Total antioxidant capacity (TAC)
Timepoint
At baseline and at the end of the study
Method of measurement
Blood sampling and using specific kit
3
Description
Hemoglobin levels
Timepoint
At baseline and at the end of the study
Method of measurement
Blood sampling
4
Description
Serum ferritin levels
Timepoint
At the beginning of the study and after three months
Method of measurement
Blood sampling
Secondary outcomes
1
Description
Drug adverse events
Timepoint
Monthly
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: The N-Acethyl Cystein Group
Category
Treatment - Drugs
2
Description
Intervention group: ،The vitamin E group
Category
Treatment - Drugs
3
Description
Control group: No treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia Clinic of Dastgheib Hospital
Full name of responsible person
Omidreza Zekavat
Street address
Shahid ayatolah Dastgheib, Beside National Garden, Hafez street, Shiraz
City
Shiraz
Province
Fars
Postal code
3769-71456
Phone
+98 71 3228 8064
Fax
Email
Dastgheib@sums.ac.ir
Web page address
http://dastgheib.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Unes Ghasemi
Street address
Shiraz University of Medical Sciences, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Sezaneh Haghpanah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Hematology research Center, 6th floor, Mohammad Rasool allah Tower, Namazee hospital, Khalili Ave, shiraz
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3612 2263
Email
haghpanah@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Omid Reza Zekavat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Hematology research Center, 6th floor, Mohammad Rasool allah Tower, Namazee hospital, Khalili Ave, shiraz
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3612 2265
Email
ozekavat@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sezaneh Haghpanah
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Hematology research Center, 6th floor, Mohammad Rasool allah Tower, Namazee hospital, Khalili Ave, shiraz
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3612 2263
Email
haghpanah@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Possibility of preparing another supllementary project