Evaluation of the effect of levothyroxine in comparison to placebo on thyroid nodule volume in patients with benign thyroid nodule during 2 year follow up
The purpose of this study is to investigate the effect of levothyroxine on the volume of benign thyroid nodule.80 patients, 20 to 60 years old, with palpable thyroid nodule in physical exam and being in euthyroid state, referring to endocrinology subspeciality clinic of Razi Hospital in Rasht city, are recruited in the study after making sure that the nodule is benign confirmed with FNA(Fine needle aspiration).Size of nodules are measured by sensitive ultrasound methods.Then patients are divided in two groups of intervention and control,with using strata random block.The patients of intervention group receive levothyroxine with the therapeutic dose of 1.8 µg/kg in which levothyroxine dose is coordinated with TSH(Thyroid-stimulating hormone) serum level after 6 weeks suppressive treatment in order to bring TSH serum level between 0.1 to 0.5 mu/l and is controlled every 3 months.The control group receives placebo with similar dose.Both groups are followed up for 24 months.Nodule size and TSH serum levels are measured and compared between two groups in the beginning, after 6 months, after 12 months ; and after 24 months of the study.Neither the patients,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:IRCT2016092624021N2
Registration date:2016-10-31, 1395/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Ahmad Alizadeh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 0370
Email address
a_alizadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2016-09-26, 1395/07/05
Expected recruitment end date
2016-10-11, 1395/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of levothyroxine in comparison to placebo on thyroid nodule volume in patients with benign thyroid nodule during 2 year follow up
Public title
evaluation of the effect of levothyroxine on benign thyroid nodule volume
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patiens with single or multi thyroid nodules that have been proved to be benign with FNA
Exclusion criteria:age under 20 and over 60; hypo or hyper thyroidism; history of using levothyroxine during past year; osteoporosis ; pregnancy; cardiovascular disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Gaz square
City
Rasht
Postal code
419389334
Approval date
2016-09-18, 1395/06/28
Ethics committee reference number
IR.GUMS.REC.1395.185
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 volume
Timepoint
beginning of assessment,6 months later after intervention , 12 months later ,18 months later , 24 months later
Method of measurement
ultrasound
Secondary outcomes
1
Description
TSH
Timepoint
before intervention, 6 weeks later, then every 3 months
Method of measurement
laboratory kit
Intervention groups
1
Description
intervention group:using levothyroxine with therapeutic dose of 1.8 µg/kg, daily, for 24 months
Category
Treatment - Drugs
2
Description
control group:using placebo half to one tablet, daily, for 24 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
Sardare Jangal Street
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
Gaz square
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
Ahmad Alizadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Sardere Jangal street
City
rasht
Postal code
95565541448
Phone
+98 13 3332 0370
Fax
Email
a_alizadeh@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
Sardare Jangal street
City
Rasht
Postal code
95565541448
Phone
+98 133320370
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
majid pour emam ali
Position
Radiology resident
Other areas of specialty/work
Street address
Sardare Jangal stree
City
Rasht
Postal code
95565541448
Phone
+98 13 3336 7356
Fax
Email
majid478@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)