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IRCT20150815023617N7 IRCT 2023-11-18 Shahid Beheshti University of Medical Sciences The effects of omega-3 supplementation in patients with Hashimoto's disease Investigating the effects of omega-3 supplementation compared to placebo on anthropometric measurements, thyroid hormone and anti-tpo concentrations, and systemic inflammation in patients with Hashimoto's disease. 2023-12-01 anticipated 60 Complete https://irct.ir/trial/72693 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomly divide people into two groups, first the patients are classified according to gender and the omega-3 group is marked with A and the placebo group is marked with B. Then, 13 blocks will be randomly selected from the table of blocks of size 4 that are combinations between A and B, and these blocks will be placed one after the other. Then 50 envelopes are prepared and the name of group A or B is placed in each envelope, so that the order of the envelopes is the same as the order of letters A and B in the selected blocks. Then the envelopes are opened in order and people are assigned to groups A and B. Omega 3 group people will receive 1000 mg of Omega 3 daily for 3 months and group B will receive a placebo that is completely similar in taste, color and appearance to Omega 3 supplements and contains sunflower oil, Blinding description: In order to perform this research in a three blinded method, at the beginning of the study, the capsules containing omega-3 supplements or placebo are coded by the factory as A and B so that the lack of information of the researcher, statistical analyst and patients of the type of supplements received by each group is observed. . 3 Hashimoto's disease. Intervention 1: Intervention group: The group receiving omega-3 supplements should take two capsules of 1000 mg of omega-3 per day with the main meals of breakfast and dinner. Intervention 2: Control group: receiving omega-3 placebo including two 1000mg capsules of omega-3 placebo (microcrystalline cellulose) daily with breakfast and dinner. Yes - There is a plan to make this available What will be shared: Only part of the data is shared, such as the primary outcome. When: The start of the access period is 12 months after printing the results. To whom: It will be available for researchers working in academic and scientific institutions. Conditions: The documentation can only be used for more complete studies in this field. Where to obtain: Dr Golbon Sohrab Faculty member (assistant professor) at Faculty of Nutrition Sciences & Food Technology, Shaheed Beheshti University of Medical Sciences Email: golbonsohrab@sbmu.ac.ir How to obtain: The communication will be possible through the electronic mail given in the previous section. Comments:
public Golbon Sohrab
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 golbonsohrab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Golbon Sohrab
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 golbonsohrab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate diagnosed with Hashimoto's thyroidits (by endocrinologist) aged between 20-70 Body mass index between 25 - 35 20 years 70 years Both Pregnancy or lactation Kidney disorders Following weight loss diets 3 months before the beginning of study Use of anti-coagulant agents, slimming and fat-burning drugs, fiber powder Presence of any blood clotting issues E06.3 Autoimmune thyroiditis Treatment - Other Placebo Intervention group: The group receiving omega-3 supplements should take two capsules of 1000 mg of omega-3 per day with the main meals of breakfast and dinner. Control group: receiving omega-3 placebo including two 1000mg capsules of omega-3 placebo (microcrystalline cellulose) daily with breakfast and dinner High sensitivity C-reactive protein (hs-CRP). Timepoint: at the beginning and end of the study. Method of measurement: ELISA method. Anti-thyroid peroxidase (Anti-TPO). Timepoint: at the beginning and end of the study. Method of measurement: ELISA method. Thyroxine (T4). Timepoint: at the beginning and end of the study. Method of measurement: ELISA method. Triiodothyronine (T3). Timepoint: at the beginning and end of the study. Method of measurement: ELISA method. Thyroid Stimulating Hormone (TSH). Timepoint: at the beginning and end of the study. Method of measurement: ELISA method. Waist circumference. Timepoint: at the beginning and end of the study. Method of measurement: measuring tape. Hips circumference. Timepoint: at the beginning and end of the study. Method of measurement: measuring tape. Waist to hips ratio. Timepoint: at the beginning and end of the study. Method of measurement: calculation. Body Mass Index (BMI). Timepoint: at the beginning and end of the study. Method of measurement: Calculation based on the weight and height of the patient. Shahid Beheshti University of Medical Sciences Approved 2023-08-14 Ethics Committee of Shahid Beheshti University Medical Sciences. Sixth floor, building number two, Shahid Beheshti University of Medical Sciences, Arabi Street, Yemen Street, Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)