The aim of this study is to investigate the effect of selenium in patients with subclinical or clinical hypothyroidism induced by Hashimoto's thyroiditis under treatment with levothyroxine. The study population will be chosen from patients with hypothyroidism that refer to Yazd University of Medical Sciences clinics (Imam Ali Clinic and Khatam Al-Anbia Clinic). The patients are devided in two groups including selenium and placebo (simple randomized method). Inclusion criteria: Positivite Anti TPO; Age between 15-50 years;
Lack of kidney and liver disorder; lack of hyperthyroidism; not pregnancy; and Exclusion criteria: company dissatisfaction with the study; irregular drug use (no more than 20% of anticipated medications); patient's desire for each Time to leave the study. The sample size was calculated according on the means comparison formula which was 52 patients (26 in the intervention group and 26 in the placebo group).
Initially, all patients with levothyroxine will be treated to keep the TSH level within the range of 0.3-5.1. Patients are then evaluated for anti TPO, T4, T3, and TSH. In the intervention group, for a period of three months, selenium 200 μg once daily administered with levothyroxine. The serum levels of thyroid hormones are listed and the clinical status of the patients is recorded and compared at the beginning and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040918858N3
Registration date:2017-09-24, 1396/07/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-24, 1396/07/02
Registrant information
Name
Masoud Rahmanian
Name of organization / entity
Diabet Research Center, Yazd Shahid Sadughi University Of Mdical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 1728 0215
Email address
rahmanian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a 3 months treatment with selenium on serum Anti TPO level in patients with Hashimoto's thyroiditis compared with placebo
Public title
Effects of a 3 months treatment with selenium on serum Anti TPO level in patients with Hashimoto's thyroiditis compared with placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Positivite Anti TPO; Age between 15-50 years;
Lack of kidney and liver disorder; lack of hyperthyroidism; not pregnancy;
Exclusion criteria: company dissatisfaction with the study; irregular drug use (no more than 20% of anticipated medications); patient's desire for each Time to leave the study
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sealed envelops
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Diabetes Research Center,Yazd University of Medical Sciences
Street address
Yazd Diabet Research Center, Talar Honar, Bahonar to Azadi Square, Shahid Sadughi Blvd, Yazd
City
yazd
Postal code
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
240139
Health conditions studied
1
Description of health condition studied
hashimoto's thyroiditis
ICD-10 code
E06.3
ICD-10 code description
Autoimmune thyroiditis
Primary outcomes
1
Description
Anti TPO
Timepoint
Before intervention and three months after intervention
Method of measurement
Laboratory kit-international units per ml
2
Description
TSH
Timepoint
Before intervention and three months after intervention
Method of measurement
Laboratory kit-international units per ml
3
Description
T3
Timepoint
Before intervention and three months after intervention
Method of measurement
Laboratory kit-Nanograms per deciliter
4
Description
T4
Timepoint
Before intervention and three months after intervention
Method of measurement
Laboratory kit-Micrograms per deciliter
5
Description
Age
Timepoint
Before intervention
Method of measurement
Years
6
Description
Sex
Timepoint
Before intervention
Method of measurement
sex
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Treatment with 200μg selenium pills once daily for 3 months+ Levothyroxin
Category
Treatment - Drugs
2
Description
control group:
Treatment with placebo once daily for 3 months+levothyroxin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Clinic, Yazd, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Masoud Rahmanian
Street address
Navab Safavi Street
City
Yazd
2
Recruitment center
Name of recruitment center
Yazd Khatamolanbia Clinic, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Masoud Rahmanian
Street address
Taleghani stree
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd medical sciences University
Full name of responsible person
Masoud Rahmanian
Street address
Yazd-Shahid Sadoughi Bolvar-Bahonar Squer-Talar Honar st
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd medical sciences University
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
Diabet Research Center, Yazd Shahid Sadughi University Of Mdical Science
Full name of responsible person
Somaye Gholami
Position
researcher
Other areas of specialty/work
Street address
Yazd diabetes research center, Talar Honar alley, shaheed sadoughi street, Yazd
City
Yazd
Postal code
Phone
+98 35 3728 0215
Fax
+98 37280216
Email
somayegholami90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Diabet Research Center
Full name of responsible person
Masoud Rahmanian
Position
Endocrinologist
Other areas of specialty/work
Street address
Yazd Diabetes Research Center, Art Hall Square, towards Azadi Square, Bahonar Square, Shahid Sadoughi Boulevard, Yazd
City
Yazd
Postal code
Phone
+98 35 3728 0228
Fax
Email
Rahmanian@ssu.ac.ir Drmasoudrahmanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Diabet Research Center, Yazd Shahid Sadughi University Of Mdical Science
Full name of responsible person
Masoud Rahmanian
Position
Endocrinologist
Other areas of specialty/work
Street address
Yazd diabetes research center, Talar Honar alley, shaheed sadoughi street, Yazd
City
Yazd
Postal code
Phone
+98 35 3728 0228
Fax
Email
Rahmanian@ssu.ac.ir Drmasoudrahmanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)