CLINICAL TRIAL FOR THE ADMINISTRATION OF VITAMIN D AS PREVENTION IN TRANSITORY HYPOCALCEMIA IN POSTOPERATORY OF TOTAL THYROIDECTOMY

CLINICAL TRIAL FOR THE ADMINISTRATION OF PREOPERATIVE VITAMIN D AS PREVENTION IN TRANSITORY HYPOCALCEMIA IN POSTOPERATORY OF TOTAL THYROIDECTOMY - AVD

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005207-30-ES

Enrollment

Unknown

Registered

2017-03-10

Start date

2017-07-21

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Transient hypocalcaemia porstoperatoria MedDRA version: 20.0 Level: LLT Classification code 10047628 Term: Vitamin deficiency System Organ Class: 100000019580

Interventions

Trade Name: HIDROFEROL Product Name: VITAMIN D Product Code: 55.315 Pharmaceutical Form: Capsule INN or Proposed INN: S/C27H44O/c1-19(2)8-6-9-21(4)25-15-16-26-22(10-7-17-27(25,26)5)12-13-23-18-24(28)1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient older than 18 years 2. Diagnosis of Multinodular Goiter 3. Be able to provide informed consent prior to randomization and agree to abide by all procedures included in the protocol. 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Previous history of hypersensitivity or allergy to any of the components of the medication used in the study. 2. Existing hypercalcemia 3. Severe hypercalciuria 4. Previous history of nephrolithiasis 5. Evidence of toxicity to vitamin D

Design outcomes

Primary

Measure	Time frame
Main Objective: To analyze the effectiveness of peroperative vitamin D therapy in patients who will undergo total thyroidectomy for benign multinodular goiter to evaluate the reduction of postoperative transient hypocalcaemia;Secondary Objective: Not applicable;Primary end point(s): Prevention of postoperative hypocalcemia in patients undergoing multinodular goiter;Timepoint(s) of evaluation of this end point: 24 h postoperative	—

Measure

Time frame

Main Objective: To analyze the effectiveness of peroperative vitamin D therapy in patients who will undergo total thyroidectomy for benign multinodular goiter to evaluate the reduction of postoperative transient hypocalcaemia;Secondary Objective: Not applicable;Primary end point(s): Prevention of postoperative hypocalcemia in patients undergoing multinodular goiter;Timepoint(s) of evaluation of this end point: 24 h postoperative

—

Secondary

Measure	Time frame
Secondary end point(s): Asymptomatic hypocalcemia Symptomatic hypocalcaemia Analytical values: Albumin and total proteins. Preoperative and postoperative PTH;Timepoint(s) of evaluation of this end point: 24 h postoperative	—

Countries

Spain

Contacts

Public ContactMarina Jiménez

Hospital Son Espases

m_js@hotmail.es+34672307721

Outcome results

None listed

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