Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia

A Phase 2, Placebo-controlled, Randomized Study to Evaluate the Effect of Pre-operative Vitamin D Supplementation on Hypocalcemia Following Total or Near-total Thyroidectomy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01868750

Enrollment

Registered

2013-06-04

Start date

2013-05-31

Completion date

2021-07-08

Last updated

2021-10-12

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

Conditions

Hypocalcemia, Thyroid Nodules

Brief summary

One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or hypocalcemia. Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities. Severe symptoms are life threatening, so it is important to start the management of these symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a few extra days in the hospital. The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the calcium needed to make strong bones and teeth. The purpose of this study is to determine if taking vitamin D before surgery to remove the thyroid gland affects whether or not you may have low calcium levels after your surgery and to test the hypothesis that those who are given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital stay.

Interventions

DIETARY_SUPPLEMENTCalcitriol

1.0ug twice daily for 7 days before surgery

DIETARY_SUPPLEMENTControl Pill

placebo pill taken twice daily for 7 days before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient referred for thyroidectomy * Agreement to use contraception prior to and during the study

Exclusion criteria

* Hypercalcemia (\>10.5mg/dL) * Chronic kidney or parathyroid disease * Cardiac or Central Nervous System disease * Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame	Description
Measure of Serum Calcium Levels	2-5 days after surgery	Serum calcium levels will be evaluated at routine intervals to identify incidences of hypocalcemia

Secondary

Measure	Time frame	Description
Evidence of Hypocalcemia	2-5 days after surgery	Measuring hypocalcemia symptoms, requirements for IV calcium, and extended hospital stay

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026