In this experimental single blind study, for assessment of the radioprotective effect of melatonin, 60 right-handed females with O+ blood-group, who receive 12 mCi iodine-131 for hyperthyroidism treatment, will be included. Patients will be randomly divided into two groups. The first group receives one capsule containing 300 mg of melatonin powder orally, 1 hour before administration of radioactive iodine. The second group receive placebo, 1 hour before administration of radioactive iodine. For both groups, blood samples will be taken just before receiving iodine and also 1 hour after. Blood lymphocytes will be assessed by micro-nuclei test for the evaluation of chromosomal damages.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090419045N1
Registration date:2014-10-07, 1393/07/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-07, 1393/07/15
Registrant information
Name
Soudabe Alidadi
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
s.alidadi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radioprotective effect of melatonin in hyperthyroid patients treated by iodine-131
Public title
Radioprotective effect of melatonin for hyperthyroidism treatment with iodine-131
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female; right-handed; blood group: O+; receiving 12 mCi iodine-131
Exclusion criteria: individuals who have genetic disorders ,cancer or chemical injuries; smokers; radiation workers; and patients undergoing chemotherapy
Age
From 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
University of Medical Sciences, Babol
City
Babol
Postal code
41367-47176
Approval date
2014-08-16, 1393/05/25
Ethics committee reference number
304447/ژ/پ
Health conditions studied
1
Description of health condition studied
Hyperthyroidism
ICD-10 code
E00-E07
ICD-10 code description
Disorders of thyroid gland
2
Description of health condition studied
Radiation damages
ICD-10 code
W88
ICD-10 code description
Exposure to ionizing radiation
Primary outcomes
1
Description
Micronuclei frequency
Timepoint
Just before iodine-131 administration; and also 1 hour after that
Method of measurement
Cytokinesis blocked micronuclei assessment
Secondary outcomes
1
Description
Thyroid gland function
Timepoint
Before intervention; and 3 months after
Method of measurement
TSH, T4 and T3 level in blood samples
Intervention groups
1
Description
Administration of a capsule containing 300 mg of melatonin powder
Category
Prevention
2
Description
Administration of a capsule containing glucose powder
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear Medicine Department, Shahid Beheshti Hospital
Full name of responsible person
Dr. Amir Gholami
Street address
Nuclear Medicine Department, Shahid Beheshti Hospital, Babol University of Medical Sciences, Babol, Iran
City
Babol
2
Recruitment center
Name of recruitment center
Alborz Nuclear Medicine Center
Full name of responsible person
Dr. Mehrangiz Amiri
Street address
Sardaran 2 St., Babol, Iran
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Moghadamnia
Street address
Babol University of Medical Sciences, Babol, Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Soudabe Alidadi
Position
MSc Student of Radiobiology
Other areas of specialty/work
Street address
Medicine Faculty, Babol University of Medical Sciences, Babol, Iran