1. Home
  2. Approved trials
  3. » فارسی

Effect of selenium therapy on primary autoimmune hypothyroidism: a randomized clinical trial

Protocol summary

Summary
Objective: to assess the effect of selenium therapy on primary autoimmune hypothyroidism Design: randomized controlled trial Setting: the eligible patients with primary autoimmune hypothyroidism who refer to endocrinology clinic of Shahid Beheshti hospital in 2012 will be enrolled Inclusion criteria: (a) age of 18 to 75 years; (b) having primary autoimmune hypothyroidisms; (c) having anti-TPO >200 U/ml Exclusion criteria: (a) history of Thyroid surgery; (b) history of thyroid cancer; (c) hypothyroidism resulted from hyperthyroidism; (d) history of auto-immune disease and known rheumatologic diseases; (e) pregnancy; (f) renal failure; (g) subclinical hypothyroidism; (h) history of using radioactive iodine, anti thyroid medication, cytotoxic; immunosuppressive, glucocorticoid, amiodaron, lithium, interferon, and chemotherapy Intervention: 20 patients with primary autoimmune hypothyroidism will receive levothyroxine plus selenium tablet 200 microgram once a day for three months Control: 20 patients with primary autoimmune hypothyroidism will receive levothyroxine only for three months Primary outcome: measurement of anti-TPO titer after three months Secondary outcome: measurement of (a) TSH, T3 and T4 titers after three months; (b) any adverse effect such as dizziness, abdominal pain, tremor, sweating, hair loss, sensation of smell of garlic

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211239014N13
Registration date: 2012-12-01, 1391/09/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-12-01, 1391/09/11
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of selenium therapy on primary autoimmune hypothyroidism: a randomized clinical trial
Public title
Effect of selenium therapy on primary autoimmune hypothyroidism: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 18 to 75 years; (b) having primary autoimmune hypothyroidisms; (c) having anti-TPO >200 U/ml Exclusion criteria: (a) history of Thyroid surgery; (b) history of thyroid cancer; (c) hypothyroidism resulted from hyperthyroidism; (d) history of auto-immune disease and known rheumatologic diseases; (e) pregnancy; (f) renal failure; (g) subclinical hypothyroidism; (h) history of using radioactive iodine, anti thyroid medication, cytotoxic; immunosuppressive, glucocorticoid, amiodaron, lithium, interferon, and chemotherapy
Age
From 14 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Local human subject review board
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-11-22, 1391/09/02
Ethics committee reference number
D-P-35-9-3040

Health conditions studied

1

Description of health condition studied
Primary autoimmune hypothyroidism
ICD-10 code
E06.3
ICD-10 code description
Autoimmune thyroiditis

Primary outcomes

1

Description
Measurement of anti-TPO titer
Timepoint
َAfter three months
Method of measurement
Through electrochemiluminescence using diasorin set and liaison kit

Secondary outcomes

1

Description
TSH
Timepoint
3 months post intervention
Method of measurement
Laboratory

2

Description
T3
Timepoint
3 months post intervention
Method of measurement
Laboratory

3

Description
T4
Timepoint
3 months post intervention
Method of measurement
Laboratory

4

Description
abdominal pain
Timepoint
3 months post intervention
Method of measurement
With question

5

Description
hair loss
Timepoint
3 months post intervention
Method of measurement
With question

6

Description
dizziness
Timepoint
3 months post intervention
Method of measurement
With question

7

Description
sensation of garlic smell
Timepoint
3 months post intervention
Method of measurement
With question

8

Description
tremor
Timepoint
3 months post intervention
Method of measurement
With question

9

Description
sweating
Timepoint
3 months post intervention
Method of measurement
With question

Intervention groups

1

Description
20 patients with primary autoimmune hypothyroidism will receive levothyroxine plus selenium tablet 200 microgram once a day for three months
Category
Treatment - Drugs

2

Description
20 patients with primary autoimmune hypothyroidism will receive levothyroxine only for three months
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Dr Mayam Vasheghani
Street address
Eram Ave. Shahid Beheshti hospital
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
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 the Technology, Hamadan 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
Research Center for Health Sciences and Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
Research Center for Health Sciences and Department of Epidemiology & Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 83 80090
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address
http://scholar.google.com/citations?user=LDEnqk8AAAAJ&hl=en

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Center for Health Sciences and Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
Research Center for Health Sciences and Department of Epidemiology & Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 83 80090
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address
http://scholar.google.com/citations?user=LDEnqk8AAAAJ&hl=en

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...