The effect of levothyroxine therapy on oxidant-antioxidant balance and CRP in patients with subclinical hypothyroidism
Design
double-blind, randomized clinical trial with control group, parallel groups, phase 3 on 30 patients. To randomize, random sequence production software was used as a block.
Settings and conduct
double-blind clinical trial -Arash Hospital
Participants/Inclusion and exclusion criteria
Patients with confirmed SCH and age between 17 and 42 years were included in the study and those with pregnancy or planning for pregnancy, history of diabetes and cardiovascular, renal and hepatic diseases, smoking and alcohol use, as well as those taking levothyroxine, lipid-lowering agents, antihypertensive drugs and those taking vitamin supplements effective on OS, were excluded from the study.
Subclinical hypothyroidism was defined as TSH level equal or greater than 5 Miu/l but below 10 mg/dl with normal thyroxin (T4) level (5-12µg/dl).
Intervention groups
Iran Hormone Pharmaceutical Company used 50 micrograms of levothyroxine daily in the intervention group and placebo drug prepared by the Faculty of Pharmacy of Tehran University of Medical Sciences was used in the control group.
Main outcome variables
Oxidant and antioxidant balance
hs-CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121001010980N4
Registration date:2020-05-28, 1399/03/08
Registration timing:retrospective
Last update:2020-05-28, 1399/03/08
Update count:0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
Nooshin Shirzad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
nshirzad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-04, 1395/01/16
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2016-04-04, 1395/01/16
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
2018-09-22, 1397/06/31
Scientific title
comparison of oxidant and anti oxidant level after levothyroxin therapy between subclinical hypothyroid patients and normal group
Public title
Evaluation of Levothyroxin therapy on Oxidant and anti Oxidant level in subclinical hypothyroid patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
age=17-42
5<=TSH>=10
NORMAL TotalT4
Exclusion criteria:
Smoking
alcohol consumption
Pregnancy and pregnancy intent
Sodium levothyroxine consumption
lipid lowering drugs
Anti hypertensive drugs
Taking vitamin supplements that affect the state of oxidative stress
History of diabetes Mellitus
- History of cardiovascular disease
History of liver disease
History of kidney disease
Age
From 17 years old to 42 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
serum sample
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
2
serum sample
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is block randomization. The unit of randomization is the individual. The randomization tool is statistical software and the method of making random sequences obtained by the software is done According to the table, coded envelopes with a random sequence were used to allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principal investigators, data collection authorities, and those who assess the outcome and patients (after obtaining written consent) are blinded to which patient was in the drug group and which patient was in the placebo group. The blinding was done using small envelopes containing medicine or placebo on which the code A or B was written based on a random table.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam khomeini hospital
Street address
Keshavarz Blv-Imam Khomeni Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.3665
Health conditions studied
1
Description of health condition studied
subclinical hypothyroidism
ICD-10 code
E03.8
ICD-10 code description
Other specified hypothyroidism
Primary outcomes
1
Description
Oxidant-Antioxidant balance
Timepoint
before intervention and 12 weeks after levothyroxin therapy
Method of measurement
serum sample.By the method of measuring prooxidant-antioxidant balance.Measurement of light spectrum by Eliza reader
2
Description
hs-CRP
Timepoint
before intervention and 12 weeks after levothyroxin
Method of measurement
serum sample.Immunoturbidometry assay with commercial kit.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Levothyroxine tablet treatment intervention group with 50 micrograms once daily orally for 3 months (Iran Hormone Company 2).
Category
Treatment - Drugs
2
Description
Control group: In this group placebo , made by the Faculty of Pharmacy of Tehran University of Medical Sciences, were given orally administered once a day for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Nooshin Shirzad
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3284
Email
hosp_arash@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Nooshin Shirzad
Street address
Endocrine and metabic research institute-Aleahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
emrc@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute
Proportion provided by this source
30
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
Tehran University of Medical Sciences
Full name of responsible person
Nooshin Shirzad
Position
Assiciate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
0098 21 ۶۱۱۹۰
Email
nshirzad11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nooshin Shirzad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrine disease
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
00982161190
Email
nshirzad11@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nooshin Shirzad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrine disease
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
00982161190
Email
nshirzad11@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
main outcome data
When the data will become available and for how long
6 months after publication
To whom data/document is available
Researchers working in scientific institutes
Under which criteria data/document could be used
Use study variables for other research in this area
From where data/document is obtainable
Nooshin Shirzad
nshirzad11@gmail.com
What processes are involved for a request to access data/document