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

Primary Purpose

Hypocalcemia

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Pak Emirates Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypocalcemia focused on measuring Cholecalciferol, post-operative hypocalcemia, thyroidectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Pak-Emirates Military HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cholecalciferol group

Control

Arm Description

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

Patients will not recieve any vitamin D before admission

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 14, 2022
Last Updated
March 27, 2023
Sponsor
Pak Emirates Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05586529
Brief Title
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia
Official Title
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pak Emirates Military Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypocalcemia
Keywords
Cholecalciferol, post-operative hypocalcemia, thyroidectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol group
Arm Type
Experimental
Arm Description
patients will recieve one dose of Vitamin D 200000 IU PO at the time of admission
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will not recieve any vitamin D before admission
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Indrop-D
Intervention Description
Cholecalciferol is vitamin D derivative and as our population already vit D deficient so post-operative hypocalcemia can be prevented.
Primary Outcome Measure Information:
Title
Post-operative hypocalcemia
Description
The primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values.
Time Frame
After 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mubashra Badar, MBBS
Phone
03145274242
Email
mubashrabadar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mubashra Badar
Organizational Affiliation
Resident
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pak-Emirates Military Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mubashra Badar, MBBS, FCPS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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