REDUCTION OF POST-THYROIDECTOMY TRANSIENT HYPOCALCEMIA WITH VITAMIN D ADMINISTERED FOR ONE MONTH BEFORE SURGERY

REDUCTION OF POST-THYROIDECTOMY TRANSIENT HYPOCALCEMIA WITH CHOLECALCIFEROL 200,000 IU OS ADMINISTERED FOR ONE MONTH BEFORE SURGERY - REDUCTION OF POST-THYROIDECTOMY TRANSIENT HYPOCALCEMIA

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002188-24-IT

Enrollment

240

Registered

2013-10-28

Start date

2014-01-16

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

Background: 30% of patients undergoing surgery for total thyroidectomy in the first 24 hours may experience a transient hypocalcaemia (serum calcium <8 mg / dl). According to recent studies, pre-surgery serum levels of vitamin D appear to predict the transient hypocalcemia, and those most at risk would be those with vitamin D insufficiency . MedDRA version: 14.1 Level: HLT Classification code 10006975 Term: Calcium metabolism disorders System Organ Class: 10027433 - Metabolism and nutrition di

Interventions

Trade Name: Dibase 25.000 ui Product Name: Dibase 25.000 UI Product Code: A11CC05 Pharmaceutical Form: Oral liquid INN or Proposed INN: colecalciferol CAS Number: 67-97-0 Current Sponsor code: A11CC05

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male and female ( age range 40-60 years) • candidates for total thyroidectomy for multinodular goiter according to current guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Prengnancy • Cancer • Creatinine Clearance <60 ml/min • Medications that interfere with the metabolism of calcium lithium, estrogen, anticonvulsants, corticosteroids, thiazide diuretics, bisphosphonates, calcium and vitamin D in the three months prior to enrollment) • Patients with previous parathyroidectomy

Design outcomes

Primary

Measure	Time frame
Main Objective: Aim of the study: administer to patients candidates for thyroidectomy for multinodular goiter cholecalciferol 50,000 IU per os a week, for 4 weeks before surgery, to achieve sufficient vitamin D levels and reduce the risk of transient hypocalcemias of at least 50% of the expected value (power 80%). ;Secondary Objective: not applicable;Primary end point(s): Primary end point: reduce the risk of transient hypocalcemias of at least 50% of the expected value (power 80%).The sample will be randomized at enrollment: 120 patients will receive oral cholecalciferol 50,000 IU per week for 4 weeks before surgery, 120 patients will have no treatment (4). The cholecalciferol will be free provided to patients from Abiogen Pharma spa. Two days before the operation will be re-evaluated the same parameters measured at enrollment. After 24 hours of surgery the incidence of hypocalcemia will be evaluated biochemically. 6 months after surgery through telephone contact, the patient will be asked to re-evaluate the possible persistence of hypocalcemia. Methods: The following parameters will be measured in the Policlinico Umberto I, at enrollment, and two days before the surgery: • Total calcium • Ionized calcium • Phosphorus • 25(OH) vitamin D • Parathyroid hormone After 24 hours and 6 months from surgery: • Ionized calcium • Parathyroid hormone ;Timepoint(s) of evaluation of this end point: Two days before the operation will be re-evaluated the same parameters measured at enrollment. After 24 hours of surgery the incidence of hypocalcemia will be evaluated biochemically. 6 months after surgery through telephone contact, the patient will be asked to re-evaluate the possible persistence of hypocalcemia.	—

Measure

Time frame

Main Objective: Aim of the study: administer to patients candidates for thyroidectomy for multinodular goiter cholecalciferol 50,000 IU per os a week, for 4 weeks before surgery, to achieve sufficient vitamin D levels and reduce the risk of transient hypocalcemias of at least 50% of the expected value (power 80%). ;Secondary Objective: not applicable;Primary end point(s): Primary end point: reduce the risk of transient hypocalcemias of at least 50% of the expected value (power 80%).The sample will be randomized at enrollment: 120 patients will receive oral cholecalciferol 50,000 IU per week for 4 weeks before surgery, 120 patients will have no treatment (4). The cholecalciferol will be free provided to patients from Abiogen Pharma spa. Two days before the operation will be re-evaluated the same parameters measured at enrollment. After 24 hours of surgery the incidence of hypocalcemia will be evaluated biochemically. 6 months after surgery through telephone contact, the patient will be asked to re-evaluate the possible persistence of hypocalcemia. Methods: The following parameters will be measured in the Policlinico Umberto I, at enrollment, and two days before the surgery: • Total calcium • Ionized calcium • Phosphorus • 25(OH) vitamin D • Parathyroid hormone After 24 hours and 6 months from surgery: • Ionized calcium • Parathyroid hormone ;Timepoint(s) of evaluation of this end point: Two days before the operation will be re-evaluated the same parameters measured at enrollment. After 24 hours of surgery the incidence of hypocalcemia will be evaluated biochemically. 6 months after surgery through telephone contact, the patient will be asked to re-evaluate the possible persistence of hypocalcemia.

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Secondary

Measure	Time frame
Secondary end point(s): no;Timepoint(s) of evaluation of this end point: no	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026