Comparing the effect of monotherapy with L-levothyroxine compared to combination therapy with L-levothyroxine and L-triiodothyronine on lipid profile of hypothyroid patients
Goal of study: The goal of this study is to compare various parameters in the patients with hypothyroidism who receiving Levothyroxine (L-T4) or combination therapy with Levothyroxine (L-T4) and L-Triiodothyronine (L_T3).
Design: This study is a randomized, single blind, clinical trial.
Inclusion criteria: New cases of hypothyroidism; Do not consumption of any thyroid hormones in the past three months
Exclusion criteria: Use of any Anti depressant agents; OCP; Anti hyperlipidemic agents; Orliestat; Breast feeding and pregnancy; Opium addiction; Myxedema coma; Use of any drug that interfere with thyroid hormones metabolism; the Patients that registered for other studies in the last month; coronary artery disease
Sample size: Seventy patients with hypothyroidism
The patients will be divided in two groups, group A (35patients) will treated with Levothyroxine and group B (35 patients) will be treated with Levothyroxine and Triiodothyronine for 6 months.
Intervention: We treat the patients in group (A) with levothyroxine 100 microgram per day and the patients in group (B) with Levothyroxine 75 microgram plus Liothyronine 12.5 microgram per day, orally. We will adjust the dose of Levothyroxine with the serum TSH level in each group. Levothroxine and Liothyronine tablets manufactured by Iran Hormone company.
Intervention time: 6 months (December; 2013 – June; 2014)
Primary outcome: Compare lipid profile, body mass index, quality of life and blood pressure in the monotherapy with Levothyroxine and combination therapy with Levothyroxine and Triiodothyronine in hypothyroid patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310204849N4
Registration date:2013-12-06, 1392/09/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-12-06, 1392/09/15
Registrant information
Name
Amir Ziaee
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0084
Email address
aziaee@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2013-12-11, 1392/09/20
Expected recruitment end date
2014-06-10, 1393/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of monotherapy with L-levothyroxine compared to combination therapy with L-levothyroxine and L-triiodothyronine on lipid profile of hypothyroid patients
Public title
Evaluation of the combination therapy with L-levothyroxine and L-triiodothyronine in hypothyroid patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: New cases of hypothyroidism; Do not consumption of any thyroid hormones in the past three months
Exclusion criteria: Use of any Anti depressant agents; OCP; Anti hyperlipidemic agents; Orliestat; Breast feeding and pregnancy; Opium addiction; Myxedema coma; Use of any drug that interfere with thyroid hormones metabolism; the Patients that registered for other studies in the last month; coronary artery disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar blvd, Vice chancellor for research, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Approval date
2013-10-14, 1392/07/22
Ethics committee reference number
28/20/7920
Health conditions studied
1
Description of health condition studied
hypothyroidism
ICD-10 code
E00, E01,
ICD-10 code description
Disorders of thyroid gland
Primary outcomes
1
Description
Lipid profile
Timepoint
Before intervention and 12 and 24 weeks after the intervention
Method of measurement
quantitative detective kits in human serum or plasma with photometric method
2
Description
Body mass index
Timepoint
Before intervention and 12 and 24 weeks after the intervention
Method of measurement
weight (Kg)/ height(m)2
3
Description
Blood pressure
Timepoint
Before intervention and 12 and 24 weeks after the intervention
Method of measurement
Manometer
4
Description
Quality of life
Timepoint
Before intervention and 12 and 24 weeks after the intervention
Method of measurement
Questionnaire
5
Description
TSH
Timepoint
Before intervention and 12 and 24 weeks after the intervention
Method of measurement
Non competitive immunoradiometric assay (IRMA) for quantitative detection of TSH in human serum or plasma with gamma counter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Monotherapy with levothyroxine 100 microgram once daily for 24 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Combination therapy with levothyroxine 75 microgram pluse triiodothyronine 12.5 microgram once daily for 24 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine Clinic of Velayat Hospital
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeed Asefzadeh
Street address
Shahid Bahonar blvd, Vice chancellor for research, Qazvin University of Medical Sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qazvin 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
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Dr.Amir Ziaee
Position
Professor, Department of Endocrinology
Other areas of specialty/work
Street address
Booali-Sina St. Booali-Sina Hospital, Qazvin Metabolic Diseases Research Center
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
aziaee1963@yahoo.com, aziaee@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Dr.Amir Ziaee
Position
Professor, Department of Endocrinology
Other areas of specialty/work
Street address
Booali-Sina St. Booali-Sina Hospital, Qazvin Metabolic Diseases Research Center
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
aziaee1963@yahoo.com, aziaee@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Dr.Amir Ziaee
Position
Professor, Department of Endocrinology
Other areas of specialty/work
Street address
Booali-Sina St. Booali-Sina Hospital, Qazvin Metabolic Diseases Research Center
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
aziee1963@yahoo.com, aziaee@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)