Hyperthyroidism has a high morbidity. The aim of this study was to evaluate the effect of methimazole pretreatment on the activity of radioactive iodine-131 in hyperthyroidism is caused by nodular goiter. The sample included 40 patients with nodular goiter is caused by hypothyroidism. The patients from 1393 to 1395 at the Hospital of Imam Reza (AS) in the division of endocrinology and metabolism at the hospital or clinic admissions are referred. The conditions of entry into the study consent to participate in this study, no previous drive therapy, older than 20 years, patients who have severe thyrotoxicosis and Exclusion criteria or contraindications to methimazole Allergies, thyroid surgery, pregnancy and breastfeeding will be. The patients selected for this study should have FT4 below 3.5 ng per deciliter or below 2 times the normal and TSH less than 0.3 mIU / ml and less than 50% RAIU 24h. Patients were randomly divided into two groups of 20 people and will be matched for age and sex. For a group as the control group only for routine radioactive iodine therapy patients will use and For groups of antithyroid drugs methimazole before administering iodine-131 at a dose of 15 mg / day for 6 weeks and then stopped for 3 days methimazole, radioactive iodine uptake is measured again and RAIU calculated on the basis of a second radioactive iodine 131 patients will be prescribed. For all patients prior to initiating therapy with any one of the protocols of thyroid hormones and RAIU the Czech base will then measured again after the end of treatment will be compared between the two groups. Volume and changes in thyroid tissue will be analyzed. During follow-up treatment will be carried out 3 months after administration of radioactive iodine TSH and FT4 will be measured again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121625550N1
Registration date:2016-02-14, 1394/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-14, 1394/11/25
Registrant information
Name
Amir Bahrami
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7850
Email address
bahramia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-01-25, 1394/11/05
Expected recruitment end date
2016-12-19, 1395/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pretreatment with methimazole the required amount of radioactive iodine to treat hyperthyroidism calculated from nodular goiter
Public title
The effect of pretreatment with methimazole the required amount of radioactive iodine to treat hyperthyroidism calculated from nodular goiter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: consent to participate in this study; no previous drive; older than 20 years; patients who have severe thyrotoxicosis
Exclusion criteria were: Allergies or contra-indications to methimazole; thyroid surgery; pregnancy and lactation
Age
From 20 years old
Gender
Female
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
Using a random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street , Tabriz
City
Tabriz
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
TBZMED.REC.1394.947
Health conditions studied
1
Description of health condition studied
Hyperthyroidism due to nodular goiter
ICD-10 code
E05.2
ICD-10 code description
Thyrotoxicosis with toxic multinodular goitre
Primary outcomes
1
Description
Radio Iodine Uptake
Timepoint
At baseline, 3 days off after a period of 6 weeks
Method of measurement
Nuclear medicine procedures
Secondary outcomes
1
Description
TSH
Timepoint
Baseline, 3 months after administration of radioactive iodine
Method of measurement
Test
2
Description
FT4
Timepoint
Baseline, 3 months after administration of radioactive iodine
Method of measurement
Test
Intervention groups
1
Description
The control group did not cause any interference
Category
N/A
2
Description
For groups of measuring the absorption of iodine, methimazole(Lughman Pharmaceutical company ) for 6 weeks with a dose of 15 mg daily is given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz, Imam Reza Hospital
Full name of responsible person
Dr. Sanaz Karimi
Street address
Department of Endocrinology, Imam Reza Hospital, Gate University, Tabriz, East Azarbaijan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
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 of 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Amir Bahrami
Position
Endocrinology and Metabolism/ Professor
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
endocrinology_tabriz@yahoo.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. Amir Bahrami
Position
Endocrinology and Metabolism/ Professor
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
endocrinology_tabriz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sanaz Karmi Aval
Position
Endocrinology and Metabolism Fellow
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Gate University, Tabriz,East Azarbaijan
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
Sanaz28aban@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)