Thyroid nodules are common and Levothyroxine are used in the treatment of nodules, its impact is still being debated and studies carried out in various countries have reported different results. This study was designed to determine the effect of levothyroxine prescription on decreasing the volume of benign thyroid nodules, in order to determine criteria to predict the effectiveness in each patient and therefore the right choice for patients prescribed levothyroxine, in addition to study the effectiveness in different patients; 132 euthyroid patients with benign thyroid nodule, with the entry conditions were studied and they were divided randomly to two groups; treatment and untreated. The intervention group treated with levothyroxine tab with an initial dose of 1 mcg per kilogram of body weight and dose adjustment created according to TSH levels measured during the period experiments. So, the level of TSH has been in the range MIU / L0.4-0.8. Untreated group uses only the routine cares.
Ultrasound was performed for all patients at the beginning as well as 6 and 12 months after starting of the study. Size and specifications of nodules recorded. Finally, results of the two groups were compared and the effectiveness of levothyroxine in reducing the size of benign thyroid nodules as well as effective relation with these criteria (criteria such as the level of TSH, the number of nodules, age, etc.) determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100918858N2
Registration date:2016-03-31, 1395/01/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-31, 1395/01/12
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 Shahid Sadoughi University of Medical Sciences Vice chancellor for research
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Levothyroxine on reduction of benign thyroid nodule's volume in euthyroid patients
Public title
The effect of Levothyroxine on reduction of Thyroid nodule's volume
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.be euthyroid; 2.non malignant nodule; 3.the age range of 18 to 65 years old.
Exclusion criteria:1.treatment with levothyroxin or methimazole; 2.patients of iodine deficiency areas; 3.history of surgery on thyroid; 4.history of head and neck radiation; 5.pregnancy; 6.nodule's cystic portion>20%; 7.heart disease(IHD-arrhythmia); 8.osteoporosis; 9. more than 3 nodules in every thyroid's lobe.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Diabet Research Center, Yazd Shahid Sadoughi Univercity of Medical Science
Street address
Yazd Diabet Research Center, Talar Honar Alley, Shahid Sadoughi Blvd, Yazd
City
Yazd
Postal code
8917693571
Approval date
2014-10-01, 1393/07/09
Ethics committee reference number
17/1/138532
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
Size of thyroid nodules
Timepoint
At the beginnig of the study and after 6 &12 months
Method of measurement
Ultrasonography
2
Description
Volume of thyroid nodule
Timepoint
At the beginnig of the study and after 6 &12 months
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
TSH
Timepoint
At the beginnig of the study; 3 months interval in treatment group and 6 months interval in control group
Method of measurement
Laboratory kit
2
Description
Anti TPO
Timepoint
At the beginnig and the end of the study
Method of measurement
Laboratory kit
3
Description
T4
Timepoint
At the beginnig of the study; 3 months interval in treatment group and 6 months interval in control group
Method of measurement
Laboratory kit
4
Description
T3
Timepoint
At the beginnig of the study; 3 months interval in treatment group and 6 months interval in control group
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group:Levothyroxin1 micro gr/kg
daily-peroral and dose modification at lenght of survey
Category
Treatment - Drugs
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetic Research Center, Yazd Shahid Sadoughi Univercity of Medical Science
Full name of responsible person
Dr. Masoud Rahmanian
Street address
Yazd Diabet Research Center, Talar Honar Alley, Shahid Sadoughi Blvd, Yazd
City
Yazd
2
Recruitment center
Name of recruitment center
Emam Ali clinic
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi Univercity of Medical Science
Full name of responsible person
Dr. Amir Hooshang Mehrparvar
Street address
Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi Univercity of Medical Science
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Diabet Research Center
Full name of responsible person
Dr. Masoud Rahmanian
Position
Endocrinologist
Other areas of specialty/work
Street address
Yazd Diabet Research Center, Talar Honar Alley, Shahid Sadoughi Blvd Yazd
City
Yazd
Postal code
Phone
+98 35 3728 0228
Fax
Email
Drmasoudrahmanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Diabet Research Center, Yazd Shahid Sadoughi Univercity of Medical Science
Full name of responsible person
Dr. Masoud Rahmanian
Position
Endocrinologist
Other areas of specialty/work
Street address
Yazd Diabet Research Center, Talar Honar Alley, Shahid Sadoughi Blvd, Yazd
City
Yazd
Postal code
8917693571
Phone
+98 35 3728 0228
Fax
Email
Drmasoudrahmanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)