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Clinical and Biochemical findings in patients with sub clinical hypothyroidism after treatment with levothyroxine

Protocol summary

Summary
The aim of this study is to assess the levothroxine effect on biochemical and clinical symptoms and signs related to hypothyroidism. Patients with subclinical hypothyroidism will be recruited in the study. Exclusion criteria are: clinical hypothyroidism, Pregnancy; thyroid or anti-thyroid medication till 1 month before study; history of coronary artery disease and arrhythmia. Thirty patients with diagnosis of subclinical hypothyroidism will be recruited from Tehran Thyroid Study. Patients will be randomly assigned in two groups (levothyroxine & placebo) for 12 months. In the intervention group , dosage will be titrated to achieve a serum TSH level between 0.3-3.5 mU/L. Main outcome measures are: systolic and diastolic blood pressure, Body Mass Index, clinical hypothyroidism scores based on modified Bilewicks questionnaire, psychomotor tests and serum concentration of thyroid antibodies, lipids, apo-lipoproteines A and B, paraxonase, prolactin, sex hormone binding globulin(SHBG), CPK, calcium, phosphorus, alkaline phosphatase and sodium before and after treatment. At the end of study data will be compared in each groups and between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201103156027N1
Registration date: 2011-05-16, 1390/02/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-16, 1390/02/26
Registrant information
Name
Sedigheh Moradi
Name of organization / entity
Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5247
Email address
s-moradi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrine and Metabolism Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2000-07-31, 1379/05/10
Expected recruitment end date
2002-01-30, 1380/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and Biochemical findings in patients with sub clinical hypothyroidism after treatment with levothyroxine
Public title
Levothyroxine therapy in sub clinical hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with subclinical hypothyroidism Exclusion criteria: Clinical hypothyroidism; Pregnancy; thyroid or Anti-thyroid medication till 1 month before study; history of coronary artery disease and arrhythmia and non cooperative patients
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Endocrine and Metabolism research center of Shahid Beheshti University of Medical Sciences
Street address
Taleghani Hospital, Yaman st.
City
Tehran
Postal code
Approval date
2000-06-21, 1379/04/01
Ethics committee reference number
522

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
Thyroid Stimulating Hormone
Timepoint
At the begining, 6 weeks after and then every 3 mo
Method of measurement
IRMA method

Secondary outcomes

1

Description
Sex hormone binding globulin(SHBG)
Timepoint
Baseline and at the end of study
Method of measurement
Radio Immuno Assay

2

Description
Creatin Phospho Kinase(CPK)
Timepoint
Baseline and at the end of study
Method of measurement
Enzymatic Colorimetry

3

Description
Body mass index(BMI)
Timepoint
Baseline and at the end of study
Method of measurement
Calculation: Weight(kg)/Height2(m)

4

Description
Hypothyroidism clinical score
Timepoint
Baseline and at the end of study
Method of measurement
Modified Bilewicz questionnaire

5

Description
Psychomotor tests
Timepoint
Baseline and at the end of study
Method of measurement
Coughlan, Ravon and Hospital anexiety depression scales( HADS) tests

6

Description
Serum concentration of thyroid antibodies
Timepoint
Baseline and at the end of study
Method of measurement
Radio Immuno Assay(RIA)

7

Description
lipids
Timepoint
Baseline and at the end of study
Method of measurement
Enzymatic colorimetry

8

Description
Apolipoproteines A and B
Timepoint
Baseline and at the end of study
Method of measurement
Torbidometry

9

Description
Paraxonase
Timepoint
Baseline and at the end of study
Method of measurement
Spectrophotometry

10

Description
Prolactin
Timepoint
Baseline and at the end of study
Method of measurement
Radio Immuno Assay

11

Description
Calcium
Timepoint
Baseline and at the end of study
Method of measurement
Chemical colorimetry

12

Description
Alkaline Phosphatase
Timepoint
Baseline and at the end of study
Method of measurement
Chemical colorimetry

13

Description
Sodium
Timepoint
Baseline and at the end of study
Method of measurement
Flame Photometry

14

Description
Phosphorous
Timepoint
Baseline and at the end of study
Method of measurement
Chemical colorimetry

15

Description
Lipoprotein A
Timepoint
Baseline and at the end of study
Method of measurement
Autoanalysis

16

Description
Systolic and Diastolic blood pressure
Timepoint
At baselina and at the end of study
Method of measurement
Standard method in Mm/Hg

Intervention groups

1

Description
Levothyroxine in active group with dose adjustment to achieve a serum TSH level between 0.3-3.5 mU/L. Levothyroxine will be used by oral in fasting state for 12 months
Category
Treatment - Drugs

2

Description
Placebo in control group, 1 tablet daily by oral root in fasting state for 12 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine and metabolism research center of Shahid Beheshti university of medical sciences
Full name of responsible person
DR Fereidoun Azizi
Street address
Taleghani HOS, Yaman st
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrine and Metabolism research center of shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Fereidoun Azizi
Street address
Endocrine and Metabolism research center, Taleghani HOS, Yaman St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrine and Metabolism research center of shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedigheh Moradi
Position
Assistant professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Endocrine and metabolism research center, Firouzgar HOS, Behafarin st
City
Tehran
Postal code
Phone
+98 21 8894 5247
Fax
Email
s-moradi@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedigheh Moradi
Position
Assistant professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Institute oe Endocrine & Metabolism research center, Firouzgar HoS, Behafarin st.
City
Tehran
Postal code
Phone
+98 21 8894 5247
Fax
Email
s-moradi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Universiyu of Medical Sciences
Full name of responsible person
Sedigheh Moradi
Position
Assistant professor, Tehran University of Medical Sciences
Other areas of specialty/work
Street address
endocrine and metabolism research center, Firouzgar HOS,Behafarin st.
City
Tehran
Postal code
Phone
+98 21889445247
Fax
Email
s-moradi@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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