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

Phase 1

• 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: 14.1Level: HLTClassification code 10006975Term: Calcium metabolism disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: HLGTClassification code 10013296Term: Bone, calcium, magnesium and phosphorus metabolism disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10020949Term: HypocalcemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-002188-24-IT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-28
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

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

•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

Study & Design

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