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Effect of levothyroxine on serum lipids in patients with subclinical hypothyroidism

Protocol summary

Summary
In this randomized clinical trial, 80 subclinical hypothyroidism patients with normal serum concentrations of FT4 and TSH range of 5.2-10 mIU/L referring to endocrine clinic of Shahid Beheshti Hospital of Qom are studied. Then the patients are randomly divided into control and case groups. For the case group, levothyroxine treatment will be initiated and the control group will receive no medications.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051417686N1
Registration date: 2014-08-29, 1393/06/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-29, 1393/06/07
Registrant information
Name
Mahmoud Parham
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2949
Email address
drparham@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of levothyroxine on serum lipids in patients with subclinical hypothyroidism
Public title
Effect of levothyroxine on serum lipids in patients with subclinical hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:subclinical hypothyroidism; Exclusion criteris: TSH>10 mIU/L; pregnancy; hyperlipidemia; serum anti-TPO Ab positivity; goiter; diabetes mellitus; ischemic heart disease.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Qom- Saheli Streeet-Qom University of Medical Sciences
City
Qom
Postal code
3719764799
Approval date
2012-10-10, 1391/07/19
Ethics committee reference number
11235/34/پ

Health conditions studied

1

Description of health condition studied
Hypothyroidism
ICD-10 code
E02
ICD-10 code description
Subclinical iodine-deficiency hypothyroidism

Primary outcomes

1

Description
LDL
Timepoint
0 and 3 months later
Method of measurement
mg/dL

2

Description
HDL
Timepoint
0 and 3 months later
Method of measurement
mg/dL

3

Description
TG
Timepoint
0 and 3 months later
Method of measurement
mg/dL

4

Description
TSH
Timepoint
0 and 3 months later
Method of measurement
mIU/L

5

Description
T4
Timepoint
0 and 3 months later
Method of measurement
ng/dL

6

Description
Cholesterol
Timepoint
0 and 3 months later
Method of measurement
mg/dL

Secondary outcomes

empty

Intervention groups

1

Description
In the case group Levothyroxine sodium (brand name Levoxin) tablet manufactured by Iran hormone pharmaceutical company with dose of 50 microgramg is used once a day for 3 months
Category
Treatment - Drugs

2

Description
No intervention is done in control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Qom
Full name of responsible person
Mahmoud Parham
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd., Qom-Iran
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd., Qom-Iran
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom 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
Qom University of Medical Sciences
Full name of responsible person
Mahmoud Parham
Position
Endocrinologist-Associate Professor
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd., Qom-Iran
City
Qom
Postal code
3719764799
Phone
+98 25 3612 2952
Fax
+98 25 3612 2949
Email
drparham@muq.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mahmoud Parham
Position
Associate professor
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd., Qom-Iran
City
Qom
Postal code
3719764799
Phone
+98 25 3612 2952
Fax
+98 25 3612 2949
Email
drparham@muq.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mahmoud Parham
Position
Endocrinologist-Associate professor
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd., Qom-Iran
City
Qom
Postal code
3719764799
Phone
+98 25 3612 2952
Fax
+98 25 3612 2949
Email
mahmoud51dr@yahoo.com
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
empty
Analytic Code
empty
Data Dictionary
empty
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