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IRCT20190610043856N1 IRCT 2020-03-17 Fasa University of Medical Sciences The effect of vitamin D replacement on patients with subclinical hypothyroidism TSH The effect of Vitamin D Replacement on patients with subclinical hypothyroidism: A randomized clinical trial 2020-01-01 anticipated 75 Complete https://irct.ir/trial/41682 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants of the study were allocated to study groups through pure chance, namely, random allocation. The method of randomization was simple; that is, each of the individual patients was randomly allocated to the intervention or control group by the use of table of random numbers. Allocation concealment was carried out; that is, the participants were not made aware of the groups to which they belonged, Blinding description: Three groups were blinded in this study: first of all, the patients who took part in this study had no idea about their group allocation and the treatment or placebo they received. Second, care providers were also blinded in this study. They were not informed of the group allocations. Nor did they have any information about the treatment or placebo each group received. Finally, the data analyser was blinded in the study; that is, he was not informed of the nature of data, the groups and the treatment/placebo. 3 Subclinical Hypothyroidism. Intervention 1: Control group:They did not receive vitamin D. Intervention 2: Intervention group: the participants of this group were treated through pearls of vitamin D, produced by Zahravi Pharmacy Co., with 50000 units weekly for two months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ali Ahmadi
Ibn Sina Square
Fasa Iran (Islamic Republic of) 7186664988 +98 71 3631 4683 a.ahmadi@fums.ac.ir Fasa University of Medical Sciences scientific Ali Ahmadi
Ibn Sina Square
Fasa Iran (Islamic Republic of) 7186664988 +98 71 3631 4683 a.ahmadi@fums.ac.ir Fasa University of Medical Sciences Iran (Islamic Republic of) Subclinical Hypothyroidism Vitamin D Deficiency no limit no limit Both Vitamin D replacement therapy in the last 15 months Overt hypothyroidism Those taking medications that affect thyroid function such as steroid and L-thyroxine Patients with symptoms of hypothyroid, Cardiovascular risk factors, Positive TPO antibody Abnormal T4 Pregnant women TSH >10 mIU/l E02 Subclinical iodine-deficiency hypothyroidism Placebo Treatment - Drugs Control group:They did not receive vitamin D. Intervention group: the participants of this group were treated through pearls of vitamin D, produced by Zahravi Pharmacy Co., with 50000 units weekly for two months. Thyroid stimulating hormone (TSH) between 5 to 10 mU/L. Timepoint: Thyroid-stimulating hormone (TSH) measurement at baseline (before intervention) and 2 months after the intervention. Method of measurement: Enzyme Linked Fluorescence Assay. Vitamin D deficiency. Timepoint: Vitamin D measurement at baseline (before intervention) and 2 months after the intervention. Method of measurement: Enzyme Linked Flourscience Assay. Fasa University of Medical Sciences Approved 2018-12-07 Ethics committee of Fasa University of Medical Science Vali-e-Asr Hospital, Fasa University of Medical Science, Ibn Sina Square, Fasa, Fars Fasa Fars Iran (Islamic Republic of)