Effect of treatment with Selenium and Vitamin C in comparison to placebo on serum level of anti-thyroid peroxidase antibody in patients with Hashimoto, thyroiditis, a clinical trial
This single blind clinical trial will be done in Kavar, east of Shiraz, with the aim of determination of the effect of treatment with Selenium and Vitamin C on anti-thyroid peroxidase antibody titer in patients with Hashimoto thyroiditis. Participants will be selected from another previous study in this area which conducted by Research Vice-Chancellor of Shiraz University of Medical Sciences. In that survey blood samples of Kavar residents were taken for different measurements including thyroid function test and anti-thyroid peroxidase antibody titer. According to their test results 84 persons will be selected by simple random sampling method. Inclusion criteria will include: age, 15 years old or more; anti-thyroid peroxidase antibody titer 200 units per liter or more. Exclusion criteria will include: pregnant women; previous history of thyroid disorders; previous history of hypothalamo-hypophyseal disorders; presence of nonthyroidal disorders (such as renal; hepatic and; cardiovascular disorders; diabetes mellitus; etc); consumption of drugs with effect on thyroid hormones metabolism; consumption of sex hormones; glucocorticoids; vitamins or supplements. The participants will be divided in three groups randomly, each group will include 28 subjects. One group will be treated with Selenium 200 microgram tablet daily, the second group will be treated with Vitamin C 500 milligram tablet daily, and the last group will receive one tablet of placebo daily for 3 to 6 months. Before and after completion of treatment period thyroid function test and titer of anti-thyroid peroxidase antibody will be checked for them
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092014717N1
Registration date:2015-05-13, 1394/02/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-13, 1394/02/23
Registrant information
Name
Fariba Karimi
Name of organization / entity
Shiraz University of Meical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 6096
Email address
karimif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-Chancellor of Shiraz University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of treatment with Selenium and Vitamin C in comparison to placebo on serum level of anti-thyroid peroxidase antibody in patients with Hashimoto, thyroiditis, a clinical trial
Public title
The effect of Selenium and Vitamin C for treatment of Hashimoto thyroiditis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age, 15 years old or more; anti-thyroid peroxidase antibody titer 200 units per liter or more.
Exclusion criteria: pregnant women; previous history of thyroid disorders; previous history of hypothalamo-hypophyseal disorders; presence of nonthyroidal disorders (such as renal; hepatic; cardiovascular disorders; diabetes mellitus; infectious diseases; renal stone; etc) ; consumption of drugs with effect on thyroid hormones metabolism; consumption of sex hormones; glucocorticoids; vitamins or supplements
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Department of Vice-Chancellor of Research of Shiraz University of Medical Sciences, 7th Floor, Central Building of Shiraz University of Medical Science, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Approval date
2012-06-14, 1391/03/25
Ethics committee reference number
۷۵۷۱/۰۴/۹/پ/۹۲/ص
Health conditions studied
1
Description of health condition studied
Hashimoto thyroiditis
ICD-10 code
E06.3
ICD-10 code description
Autoimmune thyroiditis
Primary outcomes
1
Description
Titer of anti-thyroid peroxidase antibody
Timepoint
Before and after 3 to 6 months of treatment
Method of measurement
Measurement of anti-thyroid peroxidase antibody titer in serum by radioimmunoassay method
Secondary outcomes
1
Description
Thyroid function test including: thyroxine, thriiodothyronine, and thyroid stimulating hormone levels
Timepoint
Before treatment and after completion of treatment course
Method of measurement
Measurement of serum levels of hormones by immunoradiometric assay method
Intervention groups
1
Description
The first intervention group will receive Selenium 200 micrograms tablet daily by mouth, for 3 to 6 months. Selenium tablets will be prepared from Sodium Selenate from Merck company by Shiraz school of pharmacy. The tablets will be similar to the tablets of the other two groups
Category
Treatment - Drugs
2
Description
The second intervention group will receive 500 milligrams tablet of Vitamin C daily, by mouth, for 3 to 6 months. Vitamin C tablets will be prepared by Avicenna company
Category
Treatment - Drugs
3
Description
The control group will receive one tablet of placebo which will contain starch and will be similar to the real drugs. The placebo tablets will be prepared by Shiraz school of pharmacy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kavar Health Center, dependent to Shiraz University of Medical Sciences
Full name of responsible person
Dr. Fariba Karimi
Street address
Kavar Health Center dependent to Shiraz University of Medical Sciences, Kavar, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-Chancellor of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basyr Hashemi
Street address
Department of Vice-Chancellor of Research of Shiraz University of Medical Sciences, 7th Floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
CT-P-91-3100
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-Chancellor of 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
Dr. Fariba Karimi
Position
Internist with subspecialty in Endocrinology and Metabolism, Assistant professor of Shiraz Universit
Other areas of specialty/work
Street address
Department of Internal Medicine, Namazee Hospital, Namazee Square, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4316
Fax
+98 71 3647 4316
Email
karimif@sums.ac.ir
Web page address
sumu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Fariba Karimi
Position
Internist with subspecialty in Endocrinology and Metabolism, Assistant professor of Shiraz Universit
Other areas of specialty/work
Street address
Department of Internal Medicine, Namazee Hospital, Namazee Square, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
7193711351
Phone
+98 36246096
Fax
+98 71 3647 4316
Email
karimif@sums.ac.ir,karimif2002@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Fariba Karimi
Position
Internist with subspecialty in Endocrinology and Metabolism, Assistant professor of Shiraz Universit
Other areas of specialty/work
Street address
Department of Internal Medicine, Namazee Hospital, Namazee Square, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
7193711351
Phone
+98 71 3624 6096
Fax
+98 71 3647 4316
Email
karimif@sums.ac.ir,karimif2002@yahoo.com
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)