Thyroid nodule sampling unit at Imam Reza Hospital
In this medical study, which provided patients with medication (intravenous drug), the patients and the final evaluator of the outcomes of the project that performed the analysis, were not aware of the grouping of patients.
Participants/Inclusion and exclusion criteria
in clusion criteria: euthyroid Patients aged 20-65 years with thyroid nodules who have normal pathology. with thyroid nodule of more than 1 cm in size or a multidolateral goiter with a nodule greater than 1 cm, have normal cytology . serum selenium levels were within the normal range.exclusion criteria: If the patient is unsatisfied,Thyroid nodule diagnosed as suspected or malignant. pregnant or breastfeeding.
Intervention groups
200 mg / ml selenium capsule for a period of 3 months
Main outcome variables
Thyroid nodule size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170710035001N2
Registration date:2018-05-16, 1397/02/26
Registration timing:registered_while_recruiting
Last update:2018-05-16, 1397/02/26
Update count:0
Registration date
2018-05-16, 1397/02/26
Registrant information
Name
ZEID ZEREHSAZ
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3724 5201
Email address
zerehsazz951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
State of Mashhad University of Medical Sciences
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of selenium on the size of thyroid nodules in euthyroid patients
Public title
The effect of selenium on the thyroid nodule
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
have a thyroid nodule measuring more than 1 cm in size or a multi nodular goiter with a nodule greater than 1 cm
These patients should have normal cytology (in FNA thyroid)
the serum levels of selenium should be in the normal range
Exclusion criteria:
Pregnant women
Thyroid nodule diagnosed as suspected or malignant in FNA
If the patient is not satisfied with the continuation of the study, selenium intolerance
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with seal packet
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who obtaining informed consent were entered the study and randomly assigned to one of the two groups. patients, researchers and clinical personnel not aware from belonging to the each of the two groups with drug and placebo coding .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad Holy, End of Shahid Fakoori Boulevard, between Shahid Javan Square and Shahid Al-Shahidi square, Zanjan Health
City
MASHHAD
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2017-07-09, 1396/04/18
Ethics committee reference number
IR.MUMS.FM.REC.1396.05
Health conditions studied
1
Description of health condition studied
THYROID NODULE
ICD-10 code
E04.1
ICD-10 code description
E04.1-E04.9
Primary outcomes
1
Description
Thyroid nodule size
Timepoint
Before intervention, three months after intervention
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Edible selenium capsule Use 200 micro grams per day for three months,Manufacturer of the century21 country of America
Category
Treatment - Drugs
2
Description
Control group: Taking placebo(Wheat bran),similar capsules with selenium capsules and no effective ingredients,Use 200 micro grams per day for three months,manufacturing factory:Mashhad Pharmaceutical Faculty
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Masoud Mohebi, Assistant Professor of the University
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
MASHHAD
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3840 6757
Email
ZerehsazZ951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr mohsen tafaghodi
Street address
University of Mashhad- next to Hiva Cinema - Mashhad University of Medical Sciences- Deputy of Research & Technology University -
City
MASHHAD
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3840 6757
Email
ZerehsazZ951@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
masoud mohebbi
Position
Associate professor of endocrin and Adult Metabolism
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Mashhad, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 2358
Fax
Email
MohebbiM@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Mohebbi
Position
assisstant professor of endocrinology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza hospital ,internal medicine ward
City
mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 2370
Fax
Email
mohebbim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
masoud mohebbi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 2358
Fax
Email
MohebbiM@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available