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IRCT20221016056199N2 IRCT 2026-08-25 Shiraz University of Medical Sciences Effects of vitamin D supplementation in thyroidectomy A comparative study on the efficacy of injecting versus oral vitamin D supplementation prior to thyroidectomy on reducing inflammation post-operation: A randomized parallel clinical trial 2026-09-15 anticipated 200 Pending https://irct.ir/trial/81382 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned to each intervention group based on a random list generated by computer. Eligible patients will be randomly assigned in a 1:1 ratio to each group using computer-generated permuted block randomozation sequence with variable block sizes of 4 and 6. The randomization sequence will be generated and maintained by an independent person who is not involved in data collection and analysis and will be revealed only after completion of the study and final analysis, Blinding description: Those who collect and analyze data will be blinded to patients' allocation. A certain code that identifies each group will be used and will be kept by a third person who has no role in the data collection and analysis and will not be revealed to the researchers until the end of the study. 2 Thyroid disease. Intervention 1: Intervention group: The patients in this group will receive vitamin D3 (cholecalciferol) 50,000 IU orally every day for 6 days before thyroidectomy. Intervention 2: Intervention group: The patients in this group will receive a single dose of vitamin D3 (Cholecalciferol) 300000 IU, IM injection one day before surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Maryam Hosseini
Trauma Research Center, Rajaee Hospital, Shahid Chamran Blvd
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3625 4206 hssn.mary28@yahoo.com Shiraz University of Medical Sciences scientific Maryam Hosseini
Trauma Research Center, Rajaee Hospital, Shahid Chamran Blvd
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3625 4206 hssn.mary28@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 years and older Patients who are scheduled to undergo thyroidectomy Patients with serum levels of vitamin D below 30 ng/mL 18 years no limit Both Patients who used any form of vitamin D or calcium supplementation prior to the study Patients with renal insufficiencies (eGFR ˂ 60mL/min/1.73m 2) Patients with active liver diseases Patients with any conditions that affect serum vitamin D levels or absorption of Vitamin D and calcium (such as Celiac disease or any small intestinal disorder) Patients on drugs (including steroids, antiepileptic drugs, bisphosphonates, cisplatin, aminoglycosides, diuretics, or proton pump inhibitors) Patients with cardiac diseases Patients with coagulopathies E34 Other endocrine disorders Prevention Prevention Intervention group: The patients in this group will receive vitamin D3 (cholecalciferol) 50,000 IU orally every day for 6 days before thyroidectomy Intervention group: The patients in this group will receive a single dose of vitamin D3 (Cholecalciferol) 300000 IU, IM injection one day before surgery. Inflammatory marker C-reactive protein (CRP). Timepoint: before intervention and 24 hours after thyroidectomy. Method of measurement: lab kit to measure CRP. Calcium serum level. Timepoint: before intervention and 24 hours after thyroidectomy. Method of measurement: lab kit for measuring serum calcium levels. Shiraz University of Medical Sciences Approved 2026-01-06 Ethics committee of Shiraz University of Medical Sciences Shiraz university of medical sciences, school of medicine, Emam Hossein Square, Zand Blvd Shiraz Fars Iran (Islamic Republic of)