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IRCT20210802052054N1 IRCT 2022-05-14 Tabriz University of Medical Sciences Evaluation of the effect of vitamin D consumption on the AntiTPO The effect of vitamin D intake on AntiTPO levels in hypothyroid and euthyroid patients with anti-TPO positive: an interventional study 2022-05-14 anticipated 128 Complete https://irct.ir/trial/57917 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. 2 Autoimmune Hypothyroidism. Intervention 1: Intervention group: Patients who are Anti-TPO positive and have elevated TSH and are deficient in vitamin D whose serum level of vitamin D is less than 10ng /ml . For 8 weeks, 50,000 units of vitamin D3 tablets will be prescribed every week. After 8 weeks, 800 to 1000 units of vitamin D will be prescribed daily. Intervention 2: Intervention group: Patients who are anti-TPO positive and have elevated TSH and insufficient vitamin D with serum levels of vitamin D between 10ng/ml to 20ng/ml. 800 to 1000 units of vitamin D are prescribed daily for 3 months. Intervention 3: Intervention group: Patients who are anti-TPO positive and have normal TSH and are deficient in vitamin D whose serum level of vitamin D is less than 10ng/ml. For 8 weeks, 50,000 units of vitamin D3 tablets will be prescribed every week. After 8 weeks, 800 to 1000 units of vitamin D will be prescribed daily. Intervention 4: Intervention group: Patients who are anti-TPO positive and have normal TSH and insufficient vitamin D with serum levels of vitamin D between 10ng/ml to 20ng/ml. 800 to 1000 units of vitamin D are prescribed daily for 3 months. Yes - There is a plan to make this available What will be shared: A portion of the data will be shared. When: 2023-2024 To whom: Researchers and academic staffs Conditions: For further studies Where to obtain: Request via email:ali_you_2015@yahoo.co.uk How to obtain: Request via email :ali_you_2015@yahoo.co.uk Comments:
public Sima Shahmohammadi Farid
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 1334 3010 shahmohammadis@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Sima Shahmohammadi Farid
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 1334 3010 shahmohammadis@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients of both sexes who have AntiTPO positive and their disease is approved by an endocrinologist and are in the age range of 18 to 65 years. 18 years 65 years Both Patients who have evidence of any disease that affects the balance of the immune system, such as those with type 1 diabetes, multiple sclerosis, inflammatory bowel disease, and other autoimmune diseases. Patients with impaired liver enzyme function Malnourished patients Patients with a BMI of less than 18 or more than 40. Patients with hyperthyroidism and decreased TSH levels. E06.3 Autoimmune thyroiditis Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients who are Anti-TPO positive and have elevated TSH and are deficient in vitamin D whose serum level of vitamin D is less than 10ng /ml . For 8 weeks, 50,000 units of vitamin D3 tablets will be prescribed every week. After 8 weeks, 800 to 1000 units of vitamin D will be prescribed daily. Intervention group: Patients who are anti-TPO positive and have elevated TSH and insufficient vitamin D with serum levels of vitamin D between 10ng/ml to 20ng/ml. 800 to 1000 units of vitamin D are prescribed daily for 3 months. Intervention group: Patients who are anti-TPO positive and have normal TSH and are deficient in vitamin D whose serum level of vitamin D is less than 10ng/ml. For 8 weeks, 50,000 units of vitamin D3 tablets will be prescribed every week. After 8 weeks, 800 to 1000 units of vitamin D will be prescribed daily. Intervention group: Patients who are anti-TPO positive and have normal TSH and insufficient vitamin D with serum levels of vitamin D between 10ng/ml to 20ng/ml. 800 to 1000 units of vitamin D are prescribed daily for 3 months. Serum levels of Anti TPO before and after taking vitamin D. Timepoint: Anti TPO levels are measured before the intervention and 3 and 6 months after the start of vitamin D intake. Method of measurement: After starting the study, blood samples are taken from the patients and the patients' serum is removed. Using special Anti TPO kits, the level of Anti TPO is measured by ELISA and the effect of vitamin D level on the level of Anti TPO in the serum is examined. Evaluation of serum vitamin D levels in patients with Anti TPO positive. Timepoint: Serum vitamin D levels are measured before the intervention and 3 and 6 months after the start of vitamin D intake. Method of measurement: After starting the study, blood samples are taken from the patients and the patients' serum is removed. Using special Vitamin D kits, the level of vitamin D is measured by ELISA. Tabriz University of Medical Sciences Approved 2021-09-13 Ethics committee of Tabriz University of Medical sciences Central Office of Tabriz University of Medical Sciences Tabriz -Golghasht St.- Azadi St. Tabriz East Azarbaijan Iran (Islamic Republic of)