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Study of the efficacy of Levothyroxine on pulmonary function tests in patients with subclinical hypothyroidism in comparison with Placebo

Protocol summary

Study aim
The efficacy of Levothyroxine on pulmonary function tests in patients with subclinical hypothyroidism
Design
Randomised clinical trial , Randomised to intervention and control groups ,Parallel ,Treatment purposes , Two-sided blinded ,50 samples , Each sample an individual
Settings and conduct
At the beginning all patients have pulmonary function tests by Spirometry Plethysmography and Ergospirometry devices.Then patients go under treatment by Levothyroxine or placebo for 12 weeks .At the end, pulmonary function tests would be repeated and re-evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of subclinical hypothyroidism, age 25 to 55 years old exclusion criteria: Chronic pulmonary disease, hypertension, diabetes, chronic kidney disease,chronic heart disease , stroke, receiving heart medicine (such as amiodarone, beta-blockers and calcium blockers), smoking cigarette or shisha, critical patients, pregnancy, goiter,obesity, individuals with TSH level above 10 , individuals with a history of thoracic and abdominal surgery and Patients with any systemic disease leading to myopathy.
Intervention groups
Intervention group: Levothyroxine 50 Micrograms Daily Control group: Placebo
Main outcome variables
Forced expiratory volume in 1 second (FEV1) Forced vital capacity (FVC) Forced expiratory volume in 1 second / Forced vital capacity (FEV1/FVC) Peak expiratory flow rate (PEFR) Forced expiratory flow 25–75% (FEF 25–75%) Peak expiratory Flow (PEF) Diffusing capacity of the lung for carbon monoxide (DLCO) Maximal inspiratory pressure (PIMAX) Maximal expiratory pressure (PEMAX) Functional Residual Capacity (FRC) Residual Volume (RV) Total lung capacity (TLC) VO2 (reserve) Oxygen absorption rate HR (reserve) Heart rate per minute by scale of Bpm VE: Volume of inlet or outlet gas from the lungs per minute R :The gas exchange rate R = vo2 / Vco2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180811040767N1
Registration date: 2018-11-30, 1397/09/09
Registration timing: prospective

Last update: 2018-11-30, 1397/09/09
Update count: 0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
Khadijeh Kordi Tamandani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 3407
Email address
khadijehkordi72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy of Levothyroxine on pulmonary function tests in patients with subclinical hypothyroidism in comparison with Placebo
Public title
efficacy of Levothyroxine on pulmonary function tests in patients with subclinical hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of subclinical hypothyroidism Minimum age of 25 years old Maximum age of 55 years old
Exclusion criteria:
Chronic pulmonary disease Hypertension Diabetes Chronic kidney disease Chronic heart disease Stroke Receiving heart medicine (such as amiodarone, beta-blockers and calcium blockers) Smoking cigarette or shisha Critical patients Pregnancy Goiter obesity Individuals with TSH level above 10 Individuals with a history of thoracic and abdominal surgery Patients with any systemic disease leading to myopathy
Age
From 25 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performing by a computer generated sequence ; random numbers are considered for each participant and maintained by the PI in sealed envelopes, and the patients are distributing in 2 groups of Levothyroxine or placebo according to these numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and clinical personnel such as physicians , nurses ,physiotherapists and anyone with direct contact to patients are blinded, but researcher and evaluator and DSMB (Data Saftey and Monitoring Committee) are not blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZAUMS Main campus, DoctorHesabi Square , Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.ZAUMS.REC.1397.262

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
Forced expiratory volume in 1 second (FEV1)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Spirometry

2

Description
Forced vital capacity (FVC)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Spirometry

3

Description
Forced expiratory volume in 1 second / Forced vital capacity (FEV1/FVC)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Spirometry

4

Description
Peak expiratory flow rate (PEFR)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Spirometry

5

Description
Forced expiratory flow 25–75% (FEF 25–75%)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Spirometry

6

Description
Peak expiratory Flow (PEF)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Spirometry

7

Description
Diffusing capacity of the lung for carbon monoxide (DLCO)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Plethysmography

8

Description
Maximal inspiratory pressure (PIMAX)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Plethysmography

9

Description
Maximal expiratory pressure (PEMAX)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Plethysmography

10

Description
Functional Residual Capacity (FRC)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Plethysmography

11

Description
Residual Volume (RV)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Plethysmography

12

Description
Total lung capacity (TLC)
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Plethysmography

13

Description
VO2 (reserve) Oxygen absorption rate
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Ergospirometry

14

Description
HR (reserve) Heart rate per minute by scale of Bpm
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Ergospirometry

15

Description
VE: Volume of inlet or outlet gas from the lungs per minute
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Ergospirometry

16

Description
R :The gas exchange rate R = vo2 / Vco2
Timepoint
At the beginning of the study (before the intervention) and twelve weeks after the intervention
Method of measurement
Ergospirometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Name of drug :Levothyroxine 50 Micrograms Daily made in Islamic republic of Iran by Iran Hormone Company
Category
Treatment - Drugs

2

Description
Control group: Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان فوق تخصصی علی ابن ابیطالب
Full name of responsible person
Dr.Alireza Bakhshipur
Street address
Salamat Blvd., Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5564
Fax
+98 54 3329 5563
Email
enzaums.news@zaums.ac.ir
Web page address
http://www.alihos.zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Noor Mohammad Bakhshani
Street address
ZAUMS Main campus, DoctorHesabi Square , Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Web page address
http://zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Khadijeh Kordi Tamandani
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
NO. 59, Adabiat Houses ,Kuie'Asatid , Daneshgah Ave ,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744166
Phone
+98 54 3343 3407
Email
ahmad4341@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Khadijeh Kordi Tamandani
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
NO. 59, Adabiat Houses ,Kuie'Asatid , Daneshgah Ave ,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744166
Phone
+98 54 3343 3407
Email
ahmad4341@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Khadijeh Kordi Tamandani
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
NO. 59, Adabiat Houses ,Kuie'Asatid , Daneshgah Ave ,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816744166
Phone
+98 54 3343 3407
Email
ahmad4341@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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