This study aims to investigate the effect of vitamin D treatment on TSH level in the women suffering from subclinical hypothyroidism and vitamin D deficiency. The criterion to be included in this research study was the women over 18 years affected with subclinical hypothyroidism (TSH level more than 5 and less than 10) and vitamin D deficiency (25 OHD3 less than 30), and that of exclusion from this study was the patients with systemic diseases (renal, liver or lung) and patients with chronic consumption of medication, which affect the metabolism of vitamin D, age over 65 and less than 18 years old. The population of the present study is female patients with subclinical hypothyroidism, of which a sample 25 female patients afflicted with subclinical hypothyroidism and have referred to Endocrinology Clinic in Imam Reza Tabriz Hospital or medical offices of Endocrinologists in Tabriz, were randomly chosen for this study taking into consideration the criterion of inclusion and exclusion from this research study. The intervention devised to prescribe the vitamin D to the qualified patients and investigation of its effect on the level of thyroid stimulating hormone 3 months later was a primary consequence. The time of intervention was estimated 6 months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062813612N8
Registration date:2016-09-02, 1395/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Farzad Najafipour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
najafipourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of vitamin D treatment on TSH level, in subclinical hypothyroidism & vitamin D deficient women
Public title
Effect of vitamin D treatment on TSH level, in subclinical hypothyroidism & vitamin D deficient women
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for this study: women over 18 years old; patients with subclinical hypothyroidism with TSH higher than 4.5 mlu / L and less than 10 mlu / L; patients with vitamin D deficiency who are defined with 25 (OH) D3 less than 30 mlu / L.
Exclusion criteria: patients with systemic diseases (Kidney - lung - Haematic - Digestive); taking medicatiobs that affect on the metabolism of vitamin D; older than 65 years old or younger than 18 years old; being pregnant or plan to become pregnant; patient dissatisfaction to participate in the study.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics Committee,Tabriz University of Medical Sciences, Golgasht Street , Tabriz