Assessment of the effect of Levothyroxine in comparison to placebo on nodule Volume reduction in patients with benign thyroid nodule during six months follow up
The purpose of this study is to investigate the effect of Levothyroxine on volume reduction of benign thyroid nodule. A total of 60 patients aged 20-60 years old, with palpable thyroid nodule in physical exam referring to endocrinology subspecialty clinic of Razi hospital, located in Rasht city, are recruited in the study after making sure that the nodule is benign confirmed by FNAB result from the begining and being in Euthyroid state.
Size of nodules are measured by sensitive ultrasound methods, then patients are randomly divided into two groups (intervention and control) using the table of random number distributed.
The patients of intervention group receive Levothyroxine with the therapeutic dose of 1.8 μg/Kg, in which Levothyroxine dose is coordinated with TSH serum level after 6 weeks suppressive treatment in order to bring TSH serum level between 0.1-0.5 mu/I. The control group receives placebo with similar dose. Both groups are followed up for 6 months. Nodule size and TSH serum levels are measured and compared between 2 groups in the begining and the end of the study.
Neither the patient, nor the sonographer are aware which therapy is allocated to which patient.
All patients will be enrolled in the study after giving consent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030416828N1
Registration date:2014-04-24, 1393/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-24, 1393/02/04
Registrant information
Name
Saeed Kalantari
Name of organization / entity
Guilan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1723 6186
Email address
dr_skalantari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences Vice chancellor for research
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-04-19, 1393/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Levothyroxine in comparison to placebo on nodule Volume reduction in patients with benign thyroid nodule during six months follow up
Public title
Assessment of the effect of Levothyroxine on volume reduction of Benign thyroid nodule
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with single nodule or multi nodules ; that has been proved to be benign with FNA.
Exclusion criteria: age under 20 and over 60 ; history of hypo and hyperthyroidism ; history of using Levothyroxine or other related drugs to thyroid ; pregnancy ; other diseases ( cardiovascular or liver disease )
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences Vice chancellor for research
Street address
Guilan University of Medical Sciences Vice chancellor for research , Shahid Sadati st., Namjoo st.
City
Rasht
Postal code
4193893345
Approval date
2014-02-17, 1392/11/28
Ethics committee reference number
1920422811
Health conditions studied
1
Description of health condition studied
Thyroid nodule
ICD-10 code
E00-E07
ICD-10 code description
Disorders of thyroid gland
Primary outcomes
1
Description
Thyroid nodule size
Timepoint
begining of assessment - six months later
Method of measurement
Ultrasound
Secondary outcomes
1
Description
TSH
Timepoint
before intervention and 6 weeks later and 6 months later
Method of measurement
laboratory kit
Intervention groups
1
Description
Intervention group:using Levothyroxine with Therapeutic dose of - 1/8 µgr/kg - daily- for six months
Category
Treatment - Drugs
2
Description
Control group : half to one tablet daily for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Razi hospital
Full name of responsible person
Dr. sa'eed kalantari
Street address
Razi Hospital,Sardar Jangal St.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences Vice chancellor for research
Full name of responsible person
Dr. Rasool Tabari KHomeirani
Street address
Guilan University of Medical Sciences Vice chancellor for research , Shahid Sadati st., Namjoo st.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences Vice chancellor for research
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
Razi hospital
Full name of responsible person
Sa'eed kalantari
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital,Sardar Jangal St.
City
Rasht
Postal code
95565541448
Phone
+98 13 1554 1001
Fax
Email
Dr_skalantari@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Sa'eed Kalantari
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital,Sardar Jangal St.
City
Rasht
Postal code
Phone
+98 13 1554 1001
Fax
Email
Dr_skalantari@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Hadi Ma'dankar
Position
Radiology resident
Other areas of specialty/work
Street address
Razi Hospital,Sardar Jangal St.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
hadimadankar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)