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.

A Randomised, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Preoperative Oral Vitamin D3 at Preventing Postoperative Hypocalcaemia in Patients Undergoing Total Thyroidectomy.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000201673

Acronym

Vitid Study

Enrollment

160

Registered

2014-02-25

Start date

2014-07-14

Completion date

2018-01-19

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Surgical removal of the thyroid gland is a relatively safe procedure, but can be associated with a number of specific complications. The parathyroid glands are close to the thyroid gland and can be affected by the surgery. These glands help to maintain calcium levels in the blood and damage to these glands from the surgery can result in low blood calcium levels. Low calcium levels can result in tingling, numbness and muscle cramps. The condition is usually treated with Vitamin D and calcium supplements after it occurs and may prolong the length of stay in hospital. Vitamin D is a very important vitamin that helps to control bone and calium metabolism in the body. This study wants to see if by giving Vitamin D before the surgery low calcium levels can be prevented.

Interventions

300 000 IU (6 capsules) of oral Vitamin D3 taken once, one week prior to surgery.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results