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IRCT20250627066277N1 IRCT 2025-07-18 Yasouj University of Medical Sciences Effect of Concomitant Administration of Dexamethasone and Vitamin D before Total Thyroidectomy on Temporary Postoperative Hypocalcemia The Effect of Concomitant Administration of Dexamethasone and Vitamin D before Total Thyroidectomy on Temporary Postoperative Hypocalcemia: A Clinical Trial Study 2025-07-23 anticipated 120 Complete https://irct.ir/trial/84450 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For sequential random allocation of participants to the study groups, the sample size is divided by 4, and an equal number of codes labeled A, B, C, and D are placed in a bag. Each eligible participant will draw one code from the bag before surgery, and their treatment group will be determined based on the selected code, Blinding description: Both participants and researchers are double-blinded in this study. Participants provide informed consent to take part in the study but are unaware of the content of the medication they receive. Similarly, the researchers do not know which group each participant has been assigned to. 3 Post-Thyroidectomy Hypocalcemia. Intervention 1: Intervention group 1: a single intramuscular dose of vitamin D (200,000 IU) and a single intravenous dose of dexamethasone (8 mg), Intervention group 2: a single intramuscular dose of vitamin D (200,000 IU) , Intervention group 3: a single intravenous dose of dexamethasone (8 mg). Intervention 2: Control group: No drugs given. Yes - There is a plan to make this available What will be shared: Patient data, including demographic information and laboratory results, may be published without revealing the patients' identities. When: The access period will begin after the publication of the results. To whom: The study data will be available only to researchers affiliated with academic and scientific institutions. Conditions: The data from this study will only be available for use in meta-analyses and systematic reviews. Where to obtain: To request access to the study data, please contact Dr. Saadat Mehrabi, the principal investigator, via email at dr.s.meh544@gmail.com. How to obtain: The data will be provided to the researcher as soon as possible after the email is received and the request is submitted. Comments:
public Saadat Mehrabi
Shahid Jalil Hospital, Shahid Gharani Blvd.
Yasuj Iran (Islamic Republic of) 7591387493 +98 74 3333 7001 dr.s.meh544@gmail.com Yasouj University of Medical Sciences scientific Saadat Mehrabi
Shahid Jalil hospital, Shahid Gharani Blvd, Yasuj
Yasuj Iran (Islamic Republic of) 7591387493 +98 74 3333 7001 dr.s.meh544@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 70 years Requiring total thyroidectomy Informed consent to participate in the study 18 years 70 years Both Diabetes Hypertension Corticosteroid use for more than 7 days within the past three months Pregnancy Use of medications affecting calcium metabolism History of ischemic heart disease Drug addiction Preoperative hypocalcemia Presence of parathyroid adenoma Presence of any underlying condition that affects levels of parathyroid hormone, vitamin D, calcium, or albumin (e.g., chronic kidney disease) History of major prior procedures such as total laryngectomy or parathyroidectomy E83.5 Disorders of calcium metabolism Treatment - Drugs N/A Intervention group 1: a single intramuscular dose of vitamin D (200,000 IU) and a single intravenous dose of dexamethasone (8 mg), Intervention group 2: a single intramuscular dose of vitamin D (200,000 IU) , Intervention group 3: a single intravenous dose of dexamethasone (8 mg) Control group: No drugs given Serum calcium levels before and after surgery. Timepoint: Every 12 hours for two days. Method of measurement: Serum calcium levels test. Yasouj University of Medical Sciences Approved 2025-06-19 Ethics committee of Yasuj University of Medical Sciences Shahid Gharani Blvd. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)