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

Phase 1

• Conditions: Transient hypocalcaemia porstoperatoria; MedDRA version: 20.0Level: LLTClassification code 10047628Term: Vitamin deficiencySystem Organ Class: 100000019580; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2016-005207-30-ES
• Lead Sponsor: HOSPITAL SON ESPASES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-10
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified