Effects of treatment with vitamin D3 in Hashimoto's Thyroiditis with vitamin D deficiency on Thyroid function, antithyroid antibodies and metabolic markers
Objective: The aim of this study is to evaluate the effects of treatment with vitamin D on thyroid function, metabolic markers and antithyroid antibodies in Hashimoto's thyroiditis patients with low serum vitamin D level.
Design: This study is randomized double-blind placebo-Controlled trial
Setting and conduct: The trial is undertaken in Isfahan endocrinology and metabolism research center. About 60 anti TPO positive euthyroid or hypothyroid persons with serum vitamin D level lower than 20 ng/ml are randomly assigned to receive vitamin D or placebo weekly for 12 weeks.
Inclusion and exclusion criteria: All patients are between 20 to 60 year-old; anti TPO positive with vitamin D level lower than 20ng/ml; euthyroid or hypothyroid and more than six months using current prescriptions. We exclude patients who receive Insulin or immunosuppressive drugs or dietary supplementations; confounding comorbid disease and severe weight loss.
Intervention: Blood samples will be obtained before trial and controls will receive placebo weekly for 12 weeks and target group will receive vitamin D 50000 unit weekly for 12 weeks.at the end second blood sample will be obtained.
Main outcome measurements: Anti TPO (anti tissue peroxidase);TSH (thyroid stimulating hormone );fasting blood glucose; lipid profiles; calcium; phosphorus; albumin ;parathormone (PTH) ;urea ; creatinine and insulin are measured at the beginning and the end independent pair T test is used for between and within group analysis respectively .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120520216N1
Registration date:2015-12-02, 1394/09/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Parichehr Vahabi Anaraki
Name of organization / entity
Isfahan University of Medical Science; Department of Endocrinology
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 7913
Email address
pari.vahabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology Research Center, Isfahan University of Medical Science;
Zahravy Pharmaceutical Company
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of treatment with vitamin D3 in Hashimoto's Thyroiditis with vitamin D deficiency on Thyroid function, antithyroid antibodies and metabolic markers
Public title
Effects of treatment with vitamin D3 in Hashimoto's Thyroiditis with vitamin D deficiency on Thyroid function, antithyroid antibodies and metabolic markers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 20 to 60 years;
anti thyroid peroxidase antibody positive;
serum 25 hydroxyl vitamin D 3 is less than 20 nanogram per milliliter;
euthyroid or hypothyroid;
if Levothyroxin or other metabolic drugs like Statins, Metformin consumed, starting time was more than 6 months ago.
Exclusion criteria:
immunosuppressor drugs intake before the study;
dietary supplementation intake per oral or injections before study;
comorbid disease ;
severe weight loss;
insulin taking.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
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
The patient determines her or his group by drawing one closed envelope
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Isfahan University of Medical Science
Street address
Central Organization, Isfahan University of Medical Science, Hezar Jerib Boulevard