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

Pak Emirates Military Hospital

Status: Enrolling

Conditions: Hypocalcemia

Treatments: Dietary Supplement: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT05586529

Thy 1 cpsp

Details and patient eligibility

About

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

Full 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

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Cholecalciferol group

Experimental group

Description:

patients will recieve one dose of Vitamin D 200000 IU PO at the time of admission

Treatment:

Dietary Supplement: Cholecalciferol

Control

No Intervention group

Description:

Patients will not recieve any vitamin D before admission