The purpose of this study is to investigate the effect of Levothyroxine on the serum lipids in subclinical hypothyroidism. A total of 90 patients with subclinical hypothyroidism referred to the Taleghani hospital in Kermanshah were recruited and randomly assigned into the intervention or control group. The patients in the intervention group received levothyroxine, 75 microgram in the patients with weight more than 60 and 50 microgram with weight less than 60, for three months. The patients in the control group received the same placebo with the same dose and duration. Lipid profile was measured before and after the trial and the changes were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903244179N1
Registration date:2010-10-14, 1389/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-14, 1389/07/22
Registrant information
Name
Karoon Shahebrahimi
Name of organization / entity
Kermanshah Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6303
Email address
k-shahebrahimi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Levothyroxine treatment on lipid profile in subclinical hypothyroidism
Public title
Effects of Levothyroxine on lipid profile in subclinical hypothyroidism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: High TSH with FT4 in normal range
Exclusion criteria: receiving levothyroxine, glucocorticoids, asprin, amiodaron, lipid lowering agents, OCP, dopamine antagonist eg. metoclopramide or domperidone in 6 months prior to the study, presence of diabetes mellitus, pregnancy, menopause, age older than 60 years
Age
From 14 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethics committee of Kermanshah University of Medical Sciences and Health Servises
Street address
Shahid Beheshti boulevard, Kermanshah
City
Kermanshah
Postal code
Approval date
empty
Ethics committee reference number
7/420/5358/p
Health conditions studied
1
Description of health condition studied
Subclinicsl Hypothyroidism
ICD-10 code
E02
ICD-10 code description
Subclinical iodine-deficiency hypothyroidism
Primary outcomes
1
Description
triglyceride
Timepoint
Baseline and 3 months after the intervention
Method of measurement
photometery
2
Description
cholestrol
Timepoint
Baseline and 3 months after the intervention
Method of measurement
photometery
3
Description
LDL
Timepoint
Baseline and 3 months after the intervention
Method of measurement
photometery
4
Description
HDL
Timepoint
Baseline and 3 months after the intervention
Method of measurement
photometery
5
Description
lp(a)
Timepoint
Baseline and 3 months after the intervention
Method of measurement
biochemistry
Secondary outcomes
1
Description
TSH
Timepoint
Baseline and 3 months after the intervention
Method of measurement
chemiluminescence
2
Description
FT4
Timepoint
Baseline and 3 months after the intervention
Method of measurement
chemiluminescence
Intervention groups
1
Description
Levothyroxine 50-75 microgram daily/ orally for 3 months
Category
Treatment - Drugs
2
Description
Placebo 1/2- 3/4 tab daily/ orally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic disease center of Taleghani hospital
Full name of responsible person
Dr. Tahere Sadat Kalantarian
Street address
Emam Reza Hospital, Sorkhelijeh, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti boulevard, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Emam Reza hospital
Full name of responsible person
Dr. Karoon Shahebrahimi
Position
Fellowship of adult's endocrine and metabolic disease
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
dr-Shahebrahimi@Yahoo.Com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Karoon Shahebrahimi
Position
Fellowship of adult's endocrine and metabolic disease
Other areas of specialty/work
Street address
Kermanshah- Sorkhelizhe
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
K-shahebrahimi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Tahere Sadat Kalantarian
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Emam Reza Hospital, Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
Fax
Email
t.kalantarian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)