Protective and mitigatory effect of oral vitamin C against radiation-induced serum stress oxidative in thyroid cancer patients ablated with high dose of radioiodine
This project will attempt to reduce unwanted radiation injuries in thyroid cancer patients ablated by radioiodine with evaluation of stress oxidative of serum in the presence of vitamin C. This study will be double-blind with placebo control. The study population will be patients of radioiodine therapy center of Namazi Hospital, Shiraz, Iran. Main inclusion criteria include: patients received more than 150 millicuries radioiodine; consent of the patient and exclusion criteria are the lack of patient consent. Prescription of vitamin C from 2 days before to 2 days after radioiodine therapy will be the intervention of this study. For evaluation of stress oxidative, the amount of catalase, superoxide dismutase, glutathione and malondialdehyde in serum will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041833505N1
Registration date:2017-05-26, 1396/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-26, 1396/03/05
Registrant information
Name
Esmaeil Jafari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 642 2993
Email address
stud3510171225@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Funding approved in Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-05-10, 1396/02/20
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Protective and mitigatory effect of oral vitamin C against radiation-induced serum stress oxidative in thyroid cancer patients ablated with high dose of radioiodine
Public title
Evaluating effect of vitamin C on reducing harmful effect of radioiodine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has a suitable general condition; no kidney disease; radioiodine dose more than 150 millicuries; signing informed consent. Exclusion criteria:
The patient doesn't cooperate during intervention for taking the vitamin.
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.SUMS.REC.1395.169
Health conditions studied
1
Description of health condition studied
thyroid cancer
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
Primary outcomes
1
Description
Catalase
Timepoint
Before and after intervention
Method of measurement
Reduce of absorption of H2O2 at 240nm by Spectrophotometric method
2
Description
Superoxide Dismutase
Timepoint
Before and after intervention
Method of measurement
Using Misra and Fridovich method based on the inhibition of spontaneous oxidation of adrenaline to adrenochrome by SOD in 10.2pH. Maximum light absorption of adrenochrome is at wavelength of 480nm.
3
Description
Glutathione
Timepoint
Before and after intervention
Method of measurement
Using Elman method which DTNB is added to all of Super Natants and after that absorption in 412 nm is read.
4
Description
Malondialdehyde
Timepoint
Before and after intervention
Method of measurement
Colorimetric method with a spectrophotometer at a wavelength of 532 nm and in nano gram per ml.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Used drug will be effervescent tablets of vitamin C. Intervention group will have three sub-groups.
1- A sub-group which 2 days before radioiodine therapy will start taking 3 tablets of 500 mg vitamin per day.
2- A sub-group which will start taking 3 tablets of vitamin per day after radioiodine therapy for 2 days after that.
3- A sub-groups which will start taking 3 tablets of vitamin per day from 2 days before radioiodine therapy to 2 days after that.
Category
Treatment - Drugs
2
Description
Placebo group:
A groups will be performed routine treatment. Just for placebo, water and some juice will be used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital, Shiraz
Full name of responsible person
Mehrossadat Alavi
Street address
Nuclear Medicine Department, Namazee Hospital, Zand Ave.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Seyyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Esmaeil Jafari
Position
Student/Masters student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Phone
+98 917 642 2993
Fax
Email
esmaeiljafari70@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Medical Physics
Full name of responsible person
Seyyed Mohammad Javad Mortazavi
Position
PhD in Medical Physics
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Phone
+98 71332349332
Fax
Email
mmortazavi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Esmaeil Jafari
Position
Student/ Masters student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Phone
+98 917 642 2993
Fax
Email
esmaeiljafari70@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)