The aim of this study was to investigate the effectiveness of continuous Methimazole treatment and to compare health status, and results of neuropsychological testing in patients receiving long-term continuous Methimazole to those of patients on replacement thyroxine doses following radioiodine-induced hypothyrodidm. We enrolled 239 patients with diffuse toxic goiter who had recurrence of hyperthyroidism and had been referred to an expert private clinic. One hundred and four patients were randomized into two, the methimazole and the radioiodine treatment groups. The remaining 135 patients voluntarily enrolled into two groups. After monthly visits for the first 3 months of therapy, all patients in both groups were visited every 3 months for the first year and, every 6 months thereafter. The following measurements were done for both groups: 1- questionnaires 2- physical exam and determining thyroid size 3- TSH, T3, FT4, anti TPO and TSI 4- serum lipids 5- cardiac function 6- bone mineral density 7- Neuro-psychology tests 8- treatment costs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009224794N1
Registration date:2010-10-25, 1389/08/03
Registration timing:retrospective
Last update:
Update count:1
Registration date
2010-10-25, 1389/08/03
Registrant information
Name
Fereidoun Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 9309
Email address
azizi@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
1990-03-01, 1368/12/10
Expected recruitment end date
2009-07-01, 1388/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Long-term Continuous Methimazole or Radioiodine Treatment for Hyperthyroidism
Public title
Long-term Continuous Methimazole or Radioiodine Treatment for Hyperthyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with hyperthyroidisem who need long term anti-thyroid treatment. Exclusion criteria: patients with allergic reaction to anti-thyroid drugs or anti-thyroid drug contraindication.
Age
From 21 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
239
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Street address
Next to Talegani Hospital, Velenjak
City
Tehran
Postal code
Approval date
2010-03-02, 1388/12/11
Ethics committee reference number
275EC
Health conditions studied
1
Description of health condition studied
Hyperthyroidism
ICD-10 code
E05
ICD-10 code description
Thyrotoxicosis [hyperthyroidism]
2
Description of health condition studied
anti-thyroid drugs
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Neuro-psychologic condition
Timepoint
at the beginning and end of study
Method of measurement
neuro-psychologic tests
2
Description
Goiter
Timepoint
any visit and at the end of study
Method of measurement
physical exam
3
Description
Thyroid function
Timepoint
during follow up and at the end of study
Method of measurement
laboratory
4
Description
Cardiac function
Timepoint
at the end of study
Method of measurement
echocardiography
Secondary outcomes
1
Description
lipid profiles
Timepoint
at the beginning and end of study (during study if needed)
Method of measurement
laboratory
2
Description
bone mineral density
Timepoint
at the end of study
Method of measurement
BMD
3
Description
cost
Timepoint
During follow up and at the end of study
Method of measurement
from actual ambulatory and hospital expenses during follow up
Intervention groups
1
Description
In radioiodine group, patients received 100 µCi 131I per gram of the thyroid
Category
Treatment - Other
2
Description
In the Methimazole group, patients received 10 mg of Methimazole twice daily during the first month and 10 mg daily during the second month of therapy. All patients received maintenance doses of 2.5–10 mg daily from the third month on
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Azizi's Private Clinic
Full name of responsible person
Fereidoun Azizi, M.D.
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Zadeh Vakili, PhD
Street address
Next to Taleghani Hospital,Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Sciences,Shahid Beheshti 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
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Siences
Full name of responsible person
Fereidoun Azizi, M.D.
Position
Director
Other areas of specialty/work
Street address
Next to Taleghani Hospital, Velenjak
City
Tehran
Postal code
Phone
+98 21 2240 9309
Fax
Email
azizi@endocrine.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fereidoun Azizi, M.D.
Position
Director/ professor of Internal Medicine and Endocrinology
Other areas of specialty/work
Street address
Next to Taleghani Hospital, Velenjak
City
Tehran
Postal code
Phone
+98 21 2240 9309
Fax
Email
azizi@endocrine.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Vahid Yousefi, M.D.
Position
Endocrinologist
Other areas of specialty/work
Street address
Next to Taleghani Hospital, Velenjak
City
Tehran
Postal code
IRAN
Phone
+98 21 2243 2500
Fax
Email
sv1yousefi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)