The point of this study is finding out selenium effect on thyroid size in females with hashimoto thyroiditis. based on sonography indices
Design
Randomized double blinde, two arm parallel group, placebo and selenium taking groups are designed of 60 patients and followed for 3 months
Settings and conduct
patients who refer to endocrine clinic of Loghman Hakim hspital because of thyroid problem evaluate to enter the study. An endocrinologist is care provider and Outcome assessor of our research. He selects participants based on inclusion criteria and then phones to another investigator to determine participant code.In this trial we use selenium and placebo with same package ,color and shape with different cod based on table of random numbers .Then participant refers to one radiologist for thyroid sonography with their cod. after 3 month of treatment sonography and examination repeats and findings is recorded. the end of trial findigs are analysis just with codes. Thus Participent , care provider , outcome assessor and Data analyser are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: female,age 30_60 years,Anti TPO positive,4>TSH >.4 mU/L, 0.25<Free T4<.9 pmol/L,goiter,24 hours Urine Iodine >100 microgram/L
Exclusion criteria:pregnancy,under treatment with Anti thyroid medicines,
taking supplement contain of selenium
Intervention groups
Intervention is effect of selenium taking on thyroid size compared to placebo group by sonography findings in female with hashimoto thyroiditis
Main outcome variables
thyroid size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180510039601N1
Registration date:2018-06-02, 1397/03/12
Registration timing:retrospective
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Zohreh Maghsoomi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5246
Email address
maghsoomi.z@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of selenium supplementation on Thyroid gland size in Hashimoto's thyroiditis
Public title
selenium in Hashimoto
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female
age 30_60 years
Anti TPO positive
4>TSH >.4 mU/L
0.25<Free T4<.9 pmol/L
goiter
24 hours Urine Iodine >100 microgram/L
Exclusion criteria:
pregnancy
under treatment with Anti thyroid medicines
taking supplement contain of selenium
Age
From 30 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
individual unit, simple randomization with table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
in this trial we use selenium and placebo with same package ,color and shape with different cod based on table of random numbers . An endocrinologist is care provider and Outcome assessor of research. He selects participants based on inclusion criteria and then phones to another investigator to determine participant code.then participant refers to one radiologist for thyroid sonography with their cod. after 3 month of treatment sonography and examination repeats and findings is recorded. the end of trial findigs are analysis just with codes. Thus Participent , care provider , outcome assessor and Data analyser are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences