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

Pak Emirates Military Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Cholecalciferol

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 Design

Study Type:
Anticipated Enrollment :
170 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
Official Title:
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cholecalciferol group

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

Dietary Supplement: Cholecalciferol
Cholecalciferol is vitamin D derivative and as our population already vit D deficient so post-operative hypocalcemia can be prevented.
Other Names:
  • Indrop-D
  • No Intervention: Control

    Patients will not recieve any vitamin D before admission

    Outcome Measures

    Primary Outcome Measures

    1. Post-operative hypocalcemia [After 6 months]

      The primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Pak Emirates Military Hospital


    • Principal Investigator: Mubashra Badar, Resident

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Mubashra Badar, Resident, Pak Emirates Military Hospital
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • Thy 1 cpsp
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Keywords provided by Mubashra Badar, Resident, Pak Emirates Military Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2022