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

NCT05586529 | Unknown DMC

• 1 other identifier: Thy 1 cpsp
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

Hypocalcemia

Keywords

Cholecalciferol, post-operative hypocalcemia, thyroidectomy

Outcome Measures

Primary Outcomes (1)

• Post-operative hypocalcemia

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

  After 6 months

Study Arms (2)

Cholecalciferol group

EXPERIMENTAL

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

Dietary Supplement: Cholecalciferol

Control

NO INTERVENTION

Patients will not recieve any vitamin D before admission

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

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

Also known as: Indrop-D

Cholecalciferol group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\> 18 years)
• Scheduled for TT
• Thyroid cancer treated with total thyroidectomy without lymph node dissection

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

Pak-Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypocalcemia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Mubashra Badar

  Resident

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mubashra Badar, MBBS

CONTACT

03145274242; mubashrabadar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available once published.
• Access Criteria: Any researcher who wants to buildup on this study

Locations

PA (1)