A Study to Compare Oral Vitamin D to Placebo for the Prevention of Low Calcium in the Blood after Surgery for the Total Removal of the Thyroid Gland.

Phase 3

Completed

• Conditions: Post-operative Hypocalcaemia; Total Thyroidectomy; Metabolic and Endocrine - Other metabolic disorders; Surgery - Other surgery

• Registration Number: ACTRN12614000201673
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Patients undergoing total thyroidectomy for any cause, able to provide written informed consent.
Must be able to complete follow-up.

Exclusion Criteria

-Current treatment for vitamin D deficiency at time of assessment with any form of vitamin D supplementation
-Chronic kidney disease (eGFR <60)
-Need for urgent surgery precluding completion of the intervention course
-Known primary parathyroid disease
-Pregnancy
-Current treatment with bisphosphonates
-Known severe liver disease (previous INR >1.4 without anticoagulant treatment in the presence of known liver disease, or Bilirubin > 40 in the presence of obstructive LFT profile )
-Hypercalcaemia (>2.55nmol/L) on initial pre-operative blood tests.
Refuse or are unable to provide written consent to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of low blood calcaemia (defined as any post-operative corrected calcium <2.10 mmol/L)[At 6 hours, days 1, 2, 3 (if still in hospital), 1 week, 2 weeks, 4 weeks, and 3 and 6 months post-operatively (reference range 2.10-2.55mmol/L). ]