Determining the effect of levothyroxine in comparison with placebo on serum osteocalcin levels in patients with subclinical hypothyroidism and its association with metabolic syndrome
Design
In this study, 30 patients with subclinical hypothyroidism who are admitted to the endocrinology clinic are selected. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
In this study, 30 patients with Subclinical hypothyroidism who have been admitted to study at the Endocrine clinic are selected. Participants were randomly divided into two groups of intervention and control (placebo) and serum levels of Osteocalcine were measured and compared in two groups. Medicines were prepared in two groups a and b (levothyroxine and placebo) and a specialist according to a randomisation table By the computer, the patients will be given medications. Both patient and specialist groups are blinded.
Participants/Inclusion and exclusion criteria
Admission criteria: People aged 20-40 years old referred to the endocrinology clinic; SCH have indications of treatment.
Exit criteria: A history of hypothyroidism، Treated with antithyroid drugs ، Hyperparathyroid، Acromegaly،Medicines causing thyroid disorder: Interferon،Tyrosine kinase،cortisone ، ocp and Drugs that affect insulin levels.
Intervention groups
Levothyroxine recipients
placebo recipients
Main outcome variables
Serum levels of osteocalcine
General information
Reason for update
Acronym
SCH
IRCT registration information
IRCT registration number:IRCT20171129037677N1
Registration date:2018-04-27, 1397/02/07
Registration timing:retrospective
Last update:2018-04-27, 1397/02/07
Update count:0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
reihaneh rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4234 5674
Email address
rezaeer931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of levothyroxine in comparison with placebo on serum osteocalcin levels in patients with subclinical hypothyroidism
Public title
The effect of levothyroxine in subclinical hypothyroidism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 20-40 years old referred to the endocrinology clinic
Subclinical hypothyroidism have indications of treatment(Tsh5-15 andT3-T4 in normal range)
Exclusion criteria:
History of hypothyroidism
Treated with antithyroid drugs
Metabolic bone disorder
Hypoparathyroid and hyperparathyroid
Acromegaly
Drugs that cause thyroid dysfunction: Interferon-tyrosine kinase-cortisone and ocp
Drugs that affect insulin levels
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this work, using a simple randomization model (computer randomization method), we will rank each referral in the intervention or control group based on the order of the randomization table. Statistical software is a random tool.
The randomization unit is individual. Levothyroxine and placebo will be placed in the numbered envelopes, each patient will be given an open envelope at the clinic and given the medicine..
Blinding (investigator's opinion)
Double blinded
Blinding description
Based on the randomization table that will be provided by the computer, levothyroxine and placebo will be placed in the numbered envelopes; each patient will be given an open envelope for each patient and the medication will be given to him. A list of how the patient is assigned to one of the project partners to inform him about the grouping of patients. The patient will not be aware of the grouping. During this 60 day period (treatment period), at least 1 time a month, contact persons are contacted to ensure that patients are taking drugs. Patients are also asked to do the test again at week eight after starting treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Emam Reza hospital.Bahar street
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13131
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.MUMS.fm.REC.1395.472
Health conditions studied
1
Description of health condition studied
Subclinical hypothyroidism
ICD-10 code
E02
ICD-10 code description
Subclinical iodine-deficiency hypothyroidism
Primary outcomes
1
Description
Serum osteocalcin levels
Timepoint
Measurement of osteocalcin levels before the intervention and two months later
Method of measurement
Serum level evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Levothyroxine receptor
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Reihaneh Rezaee
Street address
Bahar street,Emam reza Hospital.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3840 6757
Email
MohebbiM@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
دكتر محسن تفقدي
Street address
مشهد-خیابان دانشگاه- جنب سینما هویزه- دانشگاه علوم پزشکی مشهد- معاونت پژوهش و فناوری دانشگاه
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3840 6757
Email
rezaeer931@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
Latest degree
Subspecialist
Other areas of specialty/work
Endocinology
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
Email
MohebbiM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Mohebbi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocinology
Street address
Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13131
Phone
+98 518413006
Email
mohebbim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rezaee Reihaneh
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahar street.Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13131
Phone
+98 518413006
Email
rezaeer931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available