Vitamin D deficiency or insufficiency is a common worldwide problem. The association of between hypothyroidism and vitamin D deficiency is controversial. We aimed to evaluate the effect of vitamin D on thyroid function in hypothyroid patients.
Through a placebo-double blind randomized clinical trial study, phase 2, 201 hypothyroid patients were recruited from the three endocrinology clinics and are classified into two groups. The patients are stable for more than one year on their levothyroxine dose and TSH level is at 0.5-5 MIU/L without need to change the levothyroxine dose. The patients do not use any other drugs for any diseases. All participants are taken written consent. The demographic data such as age, sex, the presence of goiter, job, and family history of thyroid disease is completed by a questionnaire.
At the beginning of the study, serum levels of TSH, T4 and T3 are measured. The patients are randomly characterized into two group; 102 (50.7%) of people in intervention group and 99 (49.3%) of people in the control group.
The control group receive placebo addition to levothyroxine and the intervention group take 50000 IU of vitamin D weekly plus to levothyroxine for three months. At the end of three months, the measurement of thyroid hormones including serum TSH, T4 and T3 levels will repeat and the results are compared with the results of the beginning of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022325895N2
Registration date:2016-05-29, 1395/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Afsaneh Talaei
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3612
Email address
talaei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-07-01, 1394/04/10
Expected recruitment end date
2015-09-30, 1394/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of vitamin D on thyroid function in hypothyroid patients
Public title
The effect of vitamin D on hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Controlled hypothyroidism; No need to change the dose of levothyroxine; lack of the other diseases
Exclusion criteria: The presence of other disease; need to change the dose of levothyroxine
Age
From 20 years old to 57 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
201
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
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Baseej Square, Arak
City
Arak
Postal code
3848176941
Approval date
2015-04-04, 1394/01/15
Ethics committee reference number
93-169-21
Health conditions studied
1
Description of health condition studied
hypothyroidism
ICD-10 code
E03.9
ICD-10 code description
Hypothyroidism, unspecified
Primary outcomes
1
Description
The changes of TSH
Timepoint
the beginning of the study, the end of three months
Method of measurement
Blood sample
2
Description
The changes of T4
Timepoint
the beginning of the study, the end of three months
Method of measurement
Blood sample
3
Description
The changes of T3
Timepoint
the beginning of the study, the end of three months
Method of measurement
Blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: one tab 50000 per week,oral, for three months
Category
Treatment - Drugs
2
Description
Control: One tab of placebo per week ,oral,for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic
Full name of responsible person
Afsaneh Talaei
Street address
Amiralmomenin Hospital, Postal Code: 3848176941, Baseej Square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafee
Street address
Health Departmentl, Postal Code:3848176941, Arak University of Medical Sciences, Baseej Square, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Talaei
Position
Associate Professor of Endocrinology
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Postal Code:3848176941, Baseej Square, Arak
City
Arak
Postal code
Phone
+98 86 3417 3612
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afsaneh talaei
Position
Associate Professor of Endocrinology
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Postal Code:3848176941, Baseej Square, Arak
City
Arak
Postal code
Phone
+98 86 3417 3612
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Talaei
Position
Associate Professor of Endocrinology
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Postal Code:3848176941, Baseej Square, Arak
City
Arak
Postal code
Phone
+98 34173630
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)