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IRCT20090822002365N27 IRCT 2022-03-04 Iran University of Medical Sciences Effect of iron and vitamin C co-supplementation in hyperthyroidism patients Effect of iron and vitamin C co-supplementation on thyroid hormones, hematological parameters, oxidative stress, inflammation, and quality of life in hyperthyroidism patients 2022-02-20 anticipated 80 Complete https://irct.ir/trial/58352 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by blocks with size of 4. According to the sample size of 80subjects, 20 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable, Blinding description: In order to performing the double-blinded of study, before study beginning, the canisters containing tablets can be provided by someone other than the researcher, and the placebo tablets in appearance are similar to the supplementation tablets and the researcher are not be aware about the allocation of studied subjects in each group during the evaluation of the studied outcomes until the end of the intervention period. 3 Condition 1: Hyperthyroidism. Condition 2: Iron deficiency anemia. Intervention 1: Intervention group: 40 men and women with hyperthyroidism receive two tablets of 27 mg of iron supplement and 100 mg of vitamin C daily for 8 weeks each. Intervention 2: Control group: 40 men and women with hyperthyroidism, each receiving 8 placebo tablets (containing maltodextrin) daily for 8 weeks. Yes - There is a plan to make this available What will be shared: A part of the data will be shared, such as primary outcomes When: Four months after the publication of the results To whom: Researchers and students of university Conditions: Four months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis. Where to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Department of nutrition, school of health, Iran university of medical sciences, Hemmat highway, Tehran. Phone number: 0098 21 86704743. E-mail: vafa.m@iums.ac.ir How to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Department of nutrition, school of health, Iran university of medical sciences, Hemmat highway, Tehran. Phone number: 0098 21 86704743. E-mail: vafa.m@iums.ac.ir Comments:
public Mohammad Reza Vafa
Department of nutrition, School of health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4743 vafa.m@iums.ac.ir Iran University of Medical Sciences scientific Mohammad reza vafa
Department of nutrition, School of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4743 vafa.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Men and women over 18 years of age with newly diagnosed hyperthyroidism Body mass index18.5-30 kg / m2 Hemoglobin level less than 12.7 g / dl for women and less than 13 g / dl for men Start a medication program No autoimmune diseases and chronic diseases such as diabetes, hypertension, kidney, liver, gallbladder, thyroid, parathyroid, bone, gastrointestinal and hyperphosphatemia disorders No infectious diseases, malignancies and severe bleeding in the last 2 months No thalassemia and other blood disorders Do not use hormonal drugs, anticonvulsants, cholesterol and fat lowering drugs, antacids, blood thinners, and laxatives. Do not take iron and vitamin C supplements during the last month No history of other thyroid disorders In the case of women, the absence of abnormal and irregular menstrual cycles No pregnancy and lactation Willingness to cooperate 18 years no limit Both Having any acute illness Changes in medications Non-regular use of supplements and acceptance rate less than 90% Migration Exclusion based on personal preference of participants E05 D50 Thyrotoxicosis [hyperthyroidism] Iron deficiency anemia Treatment - Other Placebo Intervention group: 40 men and women with hyperthyroidism receive two tablets of 27 mg of iron supplement and 100 mg of vitamin C daily for 8 weeks each. Control group: 40 men and women with hyperthyroidism, each receiving 8 placebo tablets (containing maltodextrin) daily for 8 weeks Thyroid stimulating hormone. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: The level of TSH in serum is with ELISA method. High-sensitive C-reactive protein (hs-CRP). Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of Hs-CRP in serum is with ELISA method. Free thyroxine hormone levels. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of FT4 in serum with ELISA method. Free triiodothyronine Hormone Levels. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of FT3 in serum with ELISA method. Malondialdehyde. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of MDA in serum with ELISA method. Total antioxidant capacity. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: The level of TAC in serum with ELISA method. Hemoglobin. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Using an automated Hematology analyzer. Red blood cell. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Using an automated Hematology analyzer. Mean corpuscular volume. Timepoint: At the baseline and after 8 weeks of intervention. Method of measurement: Using an automated Hematology analyzer. Iran University of Medical Sciences Approved 2022-01-10 Ethics committee of Iran University of Medical Science Hemmat Express way, Iran University of Medical Science Tehran Tehran Iran (Islamic Republic of)