In Ghaem Hospital Endocrine Clinic, the patients were examined and according to the blood test results of the patients and the physical examination, the patients were randomly assigned to two groups. Only patients were not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: hypothyroid patients who did not received thyroid Hormon since 3 month ago that referred to endocrinology clinic of Ghaem hospital
Exclusion criteria: Acute Systemic Symptoms, Renal failure, Hepatic failure , Malabsorption illness, Use of Selenium Supplements over the past 6 months
Intervention groups
selenium group
200 mcg /ml selenium capsule for a period of 3 months & 100 mg/ml Levothyroxin made in USA Nature Made
control group
plasebo capsule for a period of 3 months & 100 mg/ml Levothyroxin made in USA Nature Made
Main outcome variables
anti TPO Ab
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180504039518N1
Registration date:2018-08-12, 1397/05/21
Registration timing:retrospective
Last update:2018-08-12, 1397/05/21
Update count:0
Registration date
2018-08-12, 1397/05/21
Registrant information
Name
Zohreh Jahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3622 6618
Email address
Jahaniz901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of selenium on anti TPO Ab in autoimmune hypothyroid patients
Public title
The effect of selenium on anti TPO Ab in autoimmune hypothyroid patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
autoimmune hypothyroid patients who did not received thyroid Hormon since 3 month ago that referred to endocrinology clinic of Ghaem hospital
Exclusion criteria:
Acute Systemic Symptoms
Renal failure
Hepatic failure
Malabsorption illness
Use of Selenium Supplements over the past 6 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization, prepared a list of all permutations for the block size. selected one of them and based on arrangement allocated participants to a treatment and control groups with sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
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
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
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
IR.MUMS.REC.1394.533
Health conditions studied
1
Description of health condition studied
autoimmune hypothyroidism
ICD-10 code
E03.8
ICD-10 code description
Other specified hypothyroidism
Primary outcomes
1
Description
Anti Thyroid Peroxidase
Timepoint
Before intervention, three months after intervention
Method of measurement
Electroluminescence Luminescence (ECL)
Secondary outcomes
1
Description
TSH
Timepoint
Before Intervention and 3 month after intervention
Method of measurement
Elisa kit lab
2
Description
Free T4
Timepoint
Before Intervention and 3 month after intervention
Method of measurement
Elisa kit lab
Intervention groups
1
Description
Intervention group: Take 200 Mcg selenium capsule per day for three months,the company that Manufactured it is Nature Made/USA and Take 100Mcg Levothyroxin per day that Manufactured by Iran Hormoune
Category
Treatment - Drugs
2
Description
Control group: placebo(Wheat bran),similar capsules with selenium capsules and no effective ingredients, the company that Manufactured it is Mashhad Pharmaceutical Faculty and Take 100Mcg Levothyroxin per day that Manufactured by Iran Hormoune
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
zahra mazloum khorasani
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 3801 2976
Fax
+98 51 3840 6757
Email
mazloumz@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
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
vcresearch@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
zahra jahani
Position
MD
Latest degree
Master
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 538012976
Email
jahaniz901@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
zahra mazloum khorasani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghaem Hospital, Parastar street, Ahmad abad Blvd, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 915 109 8005
Email
mazloumz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
zara mazloum khorasani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghaem Hospital, Parastar Street, Ahmad Abad Blvd, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 915 109 8005
Email
mazloumz@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD