Effect of intrathyroidal dexamethasone injection on the goiterous size, clinical and biochemical course of goiterous Hashimoto's thyroiditis with subclinical hypothyroidism
The overall aim of this study was to determine the effect of intrathyroidal dexamethasone injection on the goiterous size, clinical and biochemical course of goiterous Hashimoto's thyroiditis with subclinical hypothyroidism. Forty patients with the goiterous Hashimoto's thyroiditis with subclinical hypothyriditis were randomized into experimental or control group. For the patients in the intervention group, Dexamethasone injection protocol within three months with needle No 25 (0/25 mm) under ultrasound guidance was performed. The patients in the control group didn’t receive any intervention. The size of thyroid and anti-thyroid antibodies levels were assessed as primary outcome measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103023565N3
Registration date:2011-03-29, 1390/01/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-29, 1390/01/09
Registrant information
Name
Akbar Aliasgarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
asgharzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-11-05, 1389/08/14
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intrathyroidal dexamethasone injection on the goiterous size, clinical and biochemical course of goiterous Hashimoto's thyroiditis with subclinical hypothyroidism
Public title
Effect of dexamethasone on the goiterous size
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: goiterous Hashimoto's thyroiditis with subclinical hypothyroidism, TSH ≥ 10 mIU/L, AntiTPO + or AntiTG
Exclusion criteria: Age between 15 and more than70, Use of corticosteroids therapy dose in the past six months for any reason, Use of antithyroid drugs at the baseline, Psychotic and psycho somatic diseases, Atrophic form of goiterous Hashimoto's thyroiditis, no consent to participate in the study
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Postal code
Approval date
2011-02-14, 1389/11/25
Ethics committee reference number
8955
Health conditions studied
1
Description of health condition studied
Goiterous Hashimoto's thyroiditis with subclinical Hyothyroidism
ICD-10 code
E06.3
ICD-10 code description
Primary outcomes
1
Description
(TSH) Thyroid Stimulating Hormone
Timepoint
Baseline, the end of the third month and sixth month end
Method of measurement
Laboratory
Secondary outcomes
1
Description
Antibody Against Thyroid Peroxidase (Anti TPO)
Timepoint
Baseline, the end of the third month and sixth month end
Method of measurement
Laboratory
2
Description
goiterous size
Timepoint
Baseline, the end of the third month and sixth month end
Method of measurement
Radiology
Intervention groups
1
Description
Dexamethasone injection protocol within three months with needle No 25 (0/25 mm) under ultrasound guidance
Category
Treatment - Drugs
2
Description
Patients in control group followed their routine life activities without any therapeutic plan
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Azadi Street, Golgasht Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Emam Reza hospital
Full name of responsible person
Dr Akbar Aliasgharzadeha
Position
Associate Professor, Educational Assistant Section of Endocrinology
Other areas of specialty/work
Street address
Azadi Street, Golgasht Avenue, Tabriz
City
Tabriz
Postal code
Phone
+98 914 402 4918
Fax
Email
asgharzadeha@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Akbar Aliasgharzadeha
Position
Professor, Educational Assistant Section of Endocrinology
Other areas of specialty/work
Street address
Azadi Street, Golgasht Avenue, Tabriz
City
Tabriz
Postal code
Phone
+98 914 402 4918
Fax
Email
asgharzadeha@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)