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IRCT20180220038807N1 IRCT 2018-05-30 Arak University of Medical Sciences Vitamin C with levothyroxine in primary hypothyroidism Effect of vitamin C and levothyroxine on thyroid function in patients with primary hypothyroidism 2018-05-05 anticipated 189 Complete https://irct.ir/trial/30127 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized into three groups using random number blocks and using sealed envelopes, Blinding description: Patients and the person evaluating the treatment outcome will be blinded to the allocated groups. N/A Hypothyroidism. Intervention 1: Intervention group: Patients will receive levothyroxine 0.1 mg and vitamin C 1000 mg daily. Intervention 2: Intervention group: Patients will receive levothyroxine 0.1 mg and vitamin C 1000 mg daily. Intervention 3: Control group: Patients will receive levothyroxine 0.1 mg daily. 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 No further information available
public Mojtaba Alipour
Amir-almomenin Hospital, Basij square.,
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3601 m.alipour@arakmu.ac.ir Arak University of Medical Sciences scientific Mojtaba Alipour
Basij square.,
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3601 m.alipour@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) The age of 18 to 75 years of both sexes is male and female The level of patient's TSH when entering the study is between 0.5 and 4.5 Miu / l At least six months, the patient's dose of levothyroxine has not changed 18 years 75 years Both Patients with thyroid cancer, chronic gastrointestinal diseases, celiac disease, lactose intolerance, intestinal infections (Giardia lamblia), chronic lung, kidney and liver disease (cirrhosis), kidney stones, or history of kidney stones, CHF, vitamin B12 deficiency, pancreatic insufficiency As well as patients with jejunostyle or jejunoileal bypass, suffering from short-systolic syndrome or autoimmune gasteritis and H.Pylori infection Pregnant, lactating and purpose to pregnancy women Hormone-treated patients, such as taking contraceptives or estrogen and testosterone over the past three months Patients treated with any of the following drugs or compounds: ferrous sulfate, calcium carbonate, colestipol, aluminum hydroxide, sucralfate, propranolol, laxatives, levostatin, solvate ester (sevelamer), cromium picolinate, bile acid sequestrants Gastric acid antacids, sucralfate, sodium polysterone sulfonate, cholesterol, dopamine analogues, steroids, somatostatin and also anticonvulsants, raloxifene, cimetidine, amiodarone, sertraline and activated charcoal. Patients who have a change in their TSH for more than 1 unit in the first 8 weeks of their study or who have complications of vitamin C (severe nausea and vomiting or severe diarrhea) Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive levothyroxine 0.1 mg and vitamin C 1000 mg daily Intervention group: Patients will receive levothyroxine 0.1 mg and vitamin C 1000 mg daily Control group: Patients will receive levothyroxine 0.1 mg daily Thyroid function test levels. Timepoint: Before and 8 weeks after intervention. Method of measurement: By measuring serum levels of TSH and T4. Arak University of Medical Sciences Approved 2017-10-29 Ethics Committee of Arak University of Medical Sciences Arak University of Medical Sciences, Alam-ol-Hoda street, Shahid Shiroudi Ave., Arak Markazi Iran (Islamic Republic of)