Evaluation of the effect of selenium supplementation on sonographic findings of salivary glands and inflammatory factors and oxidative stress in patients with thyroid cancer treated with radioactive iodine
Determining the effect of selenium supplementation on sonographic findings of salivary glands and inflammatory factors and oxidative stress in patients with thyroid cancer treated with radioactive iodine
Design
Clinical trial, randomized, double-blind, randomized control group of 60 patients. Randomization is done using a valid website and 4-block method.
Settings and conduct
This clinical trial will be performed in the special clinic of Al-Zahra Hospital. Selenium and placebo are prescribed to the patient in exactly the same packaging. Patients and researchers will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age 20 to 65 years
Diagnosis of thyroid cancer by imaging, such as ultrasound, computed tomography, magnetic resonance imaging, and positron tomography (PET) scan
Intervention groups
Intervention group: Patients who receive a selenium capsule containing 200 micrograms of selenium per day for 10 days (3 days before treatment with radioactive iodine to 6 days after treatment with radioactive iodine).
Control group: Patients receiving a placebo capsule containing 200 micrograms of maltodextrin per day for 10 days (3 days before radioactive iodine treatment up to 6 days after radioactive iodine treatment)
Main outcome variables
Before and after studying the clinical status of salivary glands, blood CRP, oxidative stress indices including total antioxidant capacity (TAC) and total oxidative capacity (TOS) and the sense of taste and secretion of salivary glands are evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201129049534N6
Registration date:2021-09-16, 1400/06/25
Registration timing:prospective
Last update:2021-09-16, 1400/06/25
Update count:0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Mohammad bagherniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
bagherniya@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-06, 1400/07/14
Expected recruitment end date
2022-10-06, 1401/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of selenium supplementation on sonographic findings of salivary glands and inflammatory factors and oxidative stress in patients with thyroid cancer treated with radioactive iodine
Public title
Evaluation of the effect of selenium on patients with thyroid cancer treated with radioactive iodine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 20 to 65
Diagnosis of thyroid cancer by imaging, such as ultrasound, computed tomography, magnetic resonance imaging, and positron tomography (PET) scan
Exclusion criteria:
History of sialadenitis (inflammation of the salivary glands)
Sjogren's history
History of collagen vascular disease involving the salivary glands.
History of any salivary gland surgery
Follow a special diet in the last 3 months
Pregnancy and lactation
Patient dissatisfaction to participate in the study
Taking dietary supplements in the last 3 months
Suffering from certain diseases such as diseases caused by congenital diseases, immune system defects, etc.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done individually. Entry of each patient into the intervention or control group is done randomly with the help of 4 blocking. This is done using a reputable random number generation website. (Random number generation website:
https://www.sealedenvelope.com/simple-randomiser/v1/lists)
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double blinded so that the researcher and the subjects will not know which group they belong to. For blinding, selenium and placebo capsules are prepared in the same shape, color and size. These capsules are coded by someone other than the researchers (A and B) and then the capsules are given to patients. Until the end of the study and after analyzing the data, researchers will not know about the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-09-05, 1400/06/14
Ethics committee reference number
IR.MUI.MED.REC.1400.420
Health conditions studied
1
Description of health condition studied
Thyroid cancer
ICD-10 code
D44.0
ICD-10 code description
Neoplasm of uncertain behavior of thyroid gland
Primary outcomes
1
Description
Clinical status of salivary glands
Timepoint
At baseline and end of the study
Method of measurement
Ultrasound of major salivary glands (including examination of echogenicity, size, margin and contour)
2
Description
C reactive Protein (CRP)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
3
Description
Total oxidative stress
Timepoint
At baseline and end of the study
Method of measurement
Commercial diagnostic kit
4
Description
Total antioxidant capacity
Timepoint
At baseline and end of the study
Method of measurement
Commercial diagnostic kit
5
Description
Sense of taste
Timepoint
At baseline and end of the study
Method of measurement
Questionnaire designed by the researcher
6
Description
The rate of salivary gland secretion
Timepoint
At baseline and end of the study
Method of measurement
Questionnaire designed by the researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving a selenium capsule containing 200 micrograms of selenium per day for 10 days (3 days before treatment with radioactive iodine to 6 days after treatment with radioactive iodine)
Category
Treatment - Drugs
2
Description
Control group: Patients receiving a placebo capsule containing 200 micrograms of maltodextrin per day for 10 days (3 days before radioactive iodine treatment to 6 days after radioactive iodine treatment)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Sepide Amini Semiromi
Street address
Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3620 2020
Email
amini.spide@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Hagh Joy Javanmard
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3972 3138
Email
bagherniya@nutr.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Bijan Iraj
Position
Endocrinology and metabolism
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
bijaniraj@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3972 3138
Email
bagherniya@nutr.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study information will be published after the individuals are unidentified and after the project is completed.
When the data will become available and for how long
Access period starts six months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further analysis
From where data/document is obtainable
Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir
What processes are involved for a request to access data/document
After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided