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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05586529
Enrollment
170
Registered
2022-10-19
Start date
2022-11-01
Completion date
2024-12-31
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypocalcemia

Keywords

Cholecalciferol, post-operative hypocalcemia, thyroidectomy

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

Interventions

DIETARY_SUPPLEMENTCholecalciferol

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

Sponsors

Pak Emirates Military Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative hypocalcemiaAfter 6 monthsThe primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values.

Countries

Pakistan

Contacts

Primary ContactMubashra Badar, MBBS
mubashrabadar@gmail.com03145274242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026