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IRCT20210513051285N1 IRCT 2022-02-24 Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences Evaluation of the effects of calcium supplementation alone and with calcitriol in preventing the symptoms of hypocalcemia following total or near total thyroidectomy Evaluation of the prophylactic effects of oral calcium supplement alone and with calcitriol in the development of symptomatic hypocalcemia after total or near-total thyroidectomy 2021-02-08 anticipated 100 Complete https://irct.ir/trial/56499 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization of people to be in one of the three groups will be done using RandList1.2 software and as a blind, Blinding description: All patients will be informed of the objectives and method of the study and will be partially informed about the confidentiality of information and the optionality of cooperation after completing the informed consent form . The patients included in the study (about 100 people) will first be randomly divided into three groups and each group will receive a different intervention but they will not know in which group they will be placed. 3 Symptomatic hypocalcemia after total or near-total thyroidectomy. Intervention 1: Control group: Calcium will only be given if hypocalcemia occurs. Intervention 2: Intervention group: About 12 hours after surgery, when the patient is able to tolerate orally, calcium carbonate 500 mg tablets will be started and continued every 8 hours regardless of the presence or absence of hypocalcemia symptoms. Intervention 3: Intervention group: About 12 hours after surgery when the patient is able to tolerate orally, calcium carbonate 500 mg tablets and oral calcitriol0.25 μg capsules will be started regardless of the presence or absence of hypocalcemia symptoms, then calcium carbonate tablets every 8 hours and calcitriol capsules daily will be prescribed. Yes - There is a plan to make this available What will be shared: The data will be available without mentioning the name of the participant and in encrypted form When: 6 months after printing the results To whom: Vice Chancellor for Research, Journals, People Approved by the Vice Chancellor for Research Conditions: After sending the request and mentioning the reason for the request, it can be used if all members of the research agree Where to obtain: Amir Alizadeh Email: amir313.alizadeh@gmail.com How to obtain: After sending the request to the above email, the data will be available if all research members agree Comments:
public Amir Alizadeh
Daneshgah street, Imam Reza Hospital
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3920 amir313.alizadeh@gmail.com Tabriz University of Medical Sciences scientific Fariborz Rousta
Daneshgah street, Imam Reza Hospital
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3920 fariborz_roosta@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) In this study, patients who are candidates for surgery and removal of both thyroid lobes total or near-total due to multinodular goiter or thyroid cancer will be selected. no limit no limit Both Patients with preoperative hypocalcemia Patients with intraoperative parathyroid injury (mentioned by the surgeon , autograft and ischemic symptoms), Presence of parathyroid adenoma before or after surgery or any underlying disease that impairs parathyroid hormone, vitamin D, calcium, and albumin levels (such as chronic kidney disease or known diseases of malabsorption and indigestion) , Patients who have undergone extensive cervical lymphadenectomy during thyroidectomy, Patients with hypercalcemia and hypercalciuria, patients with calcium kidney stones, ventricular fibrillation, digoxin toxicity, sarcoidosis and Vit D poisoning. Patient dissatisfaction with participating in this study The presence of a previous major procedure (such as total laryngectomy and parathyroidectomy), receiving prophylactic medication for osteoporosis (including calcium and vitamin D supplementation). E89 Postprocedural endocrine and metabolic complications and disorders, not elsewhere classified N/A Prevention Prevention Control group: Calcium will only be given if hypocalcemia occurs Intervention group: About 12 hours after surgery, when the patient is able to tolerate orally, calcium carbonate 500 mg tablets will be started and continued every 8 hours regardless of the presence or absence of hypocalcemia symptoms. Intervention group: About 12 hours after surgery when the patient is able to tolerate orally, calcium carbonate 500 mg tablets and oral calcitriol0.25 μg capsules will be started regardless of the presence or absence of hypocalcemia symptoms, then calcium carbonate tablets every 8 hours and calcitriol capsules daily will be prescribed. Serum calcium level. Timepoint: Before surgery, 6 to 12 hours after surgery, 18 to 24 hours after surgery, 48 to 72 hours after surgery, next in case of recurrence of hypocalcemia and discharge time. Method of measurement: Based on laboratory tests. Clinical signs of calcium deficiency. Timepoint: Every 2 hours. Method of measurement: History and examination. Tabriz University of Medical Sciences Approved 2021-02-08 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)