Comparing serum homocysteine value in patients with hypothyroidism who are treated with folic acid and Levothyroxine with patients who receive Levothyroxine
The objective of this study was to assess the effect of combination of levothyroxine and folic acid on Homocysteine in patients with Hypothyroidism. In this double blinde clinical trial study, a total of 60 patients with hypothyroidism who referred to Endocrine Clinics of Buali Hospital, Qazvin, Iran, were assigned into 2 groups. The patients in both groups were treated with 50-100 mg levothyroxine. The patients in the intervention group received folic acid (1mg/day), as well. The patients were visited every two months until being euthyroid, and Homocysteine level was measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010024849N1
Registration date:2010-10-29, 1389/08/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-29, 1389/08/07
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
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing serum homocysteine value in patients with hypothyroidism who are treated with folic acid and Levothyroxine with patients who receive Levothyroxine
Public title
Comparing serum homocysteine value in patients treated with folic acid and Levothyroxine with patients who receive Levothyroxine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinical signs of hypothyroidism, TSH>10 mIU/L, normal function of kidney, not having systemic diseases.
Exclusion criteria: taking drugs such as Phenobarbital, Phenytoin, Tamoxifen, Methotrexate, Theophylline, having diabetes, anemia or other systemic diseases, pregnancy, smoking
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences
City
Qazvin
Postal code
Approval date
empty
Ethics committee reference number
28/20/3335
Health conditions studied
1
Description of health condition studied
Other hypothyroidism
ICD-10 code
E03.8
ICD-10 code description
Other specified hypothyroidism
Primary outcomes
1
Description
homosysteine level
Timepoint
after intervention
Method of measurement
micromole/litr
Secondary outcomes
1
Description
cardiovasicular complications
Timepoint
after intervention
Method of measurement
micromole/litr
Intervention groups
1
Description
Levothyroxine, 50-100 mg/day as well as Folic acid, 1mg/day untill being euthyroid
Category
Treatment - Drugs
2
Description
Levothyroxine, 50-100 mg/day untill being euthyroid
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine Clinic of Buali 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 Assefzadeh
Street address
Qazvin
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
Qazvin Uniersity of Medical Sciences
Full name of responsible person
Dr. Amir Ziaee
Position
Endocrinologist/Associate professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
aziaee@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Ziaee
Position
Endocrinologist/Associate perofessor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
aziaee@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)