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

The aim of this study was to investigate and compare the effectiveness of injection versus oral vitamin D supplementation before thyroidectomy on postoperative inflammation and hypocalcemia.

A randomized parallel group single blind clinical trial, phase 2, on 200 patients.

This study will be conducted in adult patients scheduled to undergo thyroidectomy. Those involved in data collection and analysis will be blinded to the patient allocation. Codes to identify the groups will be assigned and maintained by a third party not involved in data collection and analysis. These codes will not be disclosed to the investigators until the study is complete. The investigators and those responsible for data analysis will be blinded to the group allocation. The allocation to groups will be coded and the key to them will be revealed after the study is completed and the final analysis is complete.

Patients aged 18 years or older scheduled to undergo thyroidectomy will be enrolled in the study. Patients whose serum levels of vitamin D are below 30 ng/ml will be included in the study. Patients who used any form of vitamin D or calcium supplementation prior to the study, those with renal insufficiencies (eGFR ˂ 60mL/min/1.73m 2), active liver diseases, any conditions that affect serum vitamin D levels or absorption of Vitamin D and calcium (such as celiac disease or small intestinal disorder), drugs (including steroids, antiepileptic drugs, bisphosphonates, cisplatin, aminoglycosides, diuretics, or proton pump inhibitors), cardiac diseases and coagulopathies will be excluded.

One group will receive vitamin D3 (cholecalciferol) 50,000 IU orally every day for 6 days before surgery, and the other group will receive a single dose of vitamin D3 (Cholecalciferol) 300,000 IU, IM injection one day before surgery.

The primary outcome will be the changes in inflammatory marker including CRP and calcium levels, after thyroidectomy.

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.

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.

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