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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Hypocalcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cholecalciferol group

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

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Control

Patients will not recieve any vitamin D before admission

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cholecalciferol

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Indrop-D

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes