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Study aim
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The effect of some micronutrients including selenium, zinc, magnesium, vitamin A and vitamin D compared with placebo consumption on thyroid function, lipid profile and glycemic status in hypothyroid patients
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Design
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Controlled clinical trial, with parallel groups, triple blinded, randomized, phase 3, on 90 patients, non-block random allocation will be used for randomization
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Settings and conduct
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Hypothyroid patients referred to the hospital, after evaluating the inclusion criteria, are intervened within 8 weeks and their thyroid, lipid and glycemic factors are evaluated. Patients, researchers and data analyser are unaware of the type of intervention of each patient.
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Participants/Inclusion and exclusion criteria
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Hypothyroid patients candidates for levothyroxine, age 19 to 65 years, not to take vitamin D orally or by injection during the last 2-3 months, willingness to participate in the study
No entry: Smoking or taking addictive drugs or alcohol, Pregnancy and breastfeeding, Chronic renal failure, diabetes, other autoimmune diseases and malignancies or taking certain medications, History of various thyroid diseases, as well as critical condition, taking dietary supplements or following a low-calorie diet through last 3 months
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Intervention groups
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Intervention group: One daily capsule of selenium plus supplement or an alternative, plus one daily capsule of cmz supplement or an alternative, and once a week, one of 50,000 international unit of vitamin D supplement during 8 weeks
Control group: placebo capsule with the same schedule
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Main outcome variables
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Thyroid function (thyroid stimulating hormone, anti thyroid peroxidase), lipid profile (serum triglyceride, total cholesterole, high density lipoprotein, low density lipoprotein) and glycemic status (fasting blood sugar,fasting insulin, homeostatic model assessment for insulin resistance )