Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia

Not Applicable

Recruiting

• Conditions: Hypocalcemia
• Interventions: Dietary Supplement: Cholecalciferol

• Registration Number: NCT05586529
• Lead Sponsor: Pak Emirates Military Hospital

Brief Summary

Hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia. What has not been examined so far is whether and how routine preoperative cholecalciferol prophylaxis can help to prevent postoperative hypocalcaemia

Detailed Description

Hypocalcemia following thyroid surgery is caused either due to parathyroid devascularization, stunning, or accidental removal of the parathyroid glandsMultiple risk factors have been identified which predispose patients to develop post-operative hypocalcemia. In light of the available evidence of prevalent vitamin D deficiency in the general population, and the observation of appearance of postthyroidectomy hypocalcemic symptoms at a much earlier stage than documented in previous literature, we postulate that a prophylactic vitamin D supplementation dose given in immediate preoperative period can significantly reduce acute symptomatic postoperative hypocalcemia in patients undergoing thyroid surgery

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-19
• Study Start: 2022-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2023-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Adult patients (> 18 years)
• Scheduled for TT
• Thyroid cancer treated with total thyroidectomy without lymph node dissection

Exclusion Criteria

• Lack of written consent
• Thyroid cancer treated with TT and lymph node dissection
• Mediastinal goiter with need for sternotomy
• Medication with thiazide diuretics, digitalis or lithium therapy
• Previous neck operations or radiation
• Preexisting hyperparathyroidism
• Chronic kidney failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol group	Cholecalciferol	patients will recieve one dose of Vitamin D 200000 IU PO at the time of admission

Primary Outcome Measures

Name	Time	Method
Post-operative hypocalcemia	After 6 months	The primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values.

Trial Locations

Locations (1)

Pak-Emirates Military Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan