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

March 27, 2023 updated by: Mubashra Badar, Pak Emirates Military Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan
        • Recruiting
        • Pak-Emirates Military Hospital
        • Contact:
          • Mubashra Badar, MBBS, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pak Emirates Military Hospital

Investigators

  • Principal Investigator: Mubashra Badar, Resident

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thy 1 cpsp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will publish this article and all the available darra will be available for researchers to view.

IPD Sharing Time Frame

Data will be available once published.

IPD Sharing Access Criteria

Any researcher who wants to buildup on this study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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