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NCT05586529 Clinical Trial

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

Hypocalcemia Clinical Trial

Official title:
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05586529
Other study ID # Thy 1 cpsp
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 2024

Study information
Verified date March 2023
Source Pak Emirates Military Hospital
Contact Mubashra Badar, MBBS
Phone 03145274242
Email mubashrabadar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 170
Est. completion date December 2024
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Cholecalciferol
Cholecalciferol is vitamin D derivative and as our population already vit D deficient so post-operative hypocalcemia can be prevented.

Locations
Country Name City State
Pakistan Pak-Emirates Military Hospital Rawalpindi Punjab

Sponsors (1)
Lead Sponsor Collaborator
Pak Emirates Military Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative hypocalcemia The primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values. After 6 months
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