Prevention of Postoperative Hypocalcemia of Oral Vitamin D Supplementation Before Total Thyroidectomy

April 16, 2024 updated by: Su-jin Kim, Seoul National University Hospital

Study for Effectiveness in Prevention of Postoperative Hypocalcemia of Preoperative Oral Supplementation of Vitamin D (D-mac 30,000 IU) in Patients Undergoing Total Thyroidectomy

The hypocalcemia after total thyroidectomy is one of common surgical complications. It may be asymptomatic, but patients can complain of dysfunction around the mouth or extremities, stiffness or convulsion in severe cases. The incidence of transient hypocalcemia was 6.9-46%, and permanent hypocalcemia was reported to be 0.4-33%. It has been reported that the incidence of hypocalcemia after thyroidectomy is high when the difference in blood levels of parathyroid hormone and vitamin D is large before and after surgery.

Therefore, it is a very important task to study the effect of using vitamin D3 (cholecalciferol), which has a better effect on the human body, on the prevention of hypocalcemia after total thyroidectomy with a long follow-up period after surgery. The department of surgery in Seoul National University Hospital intends to analyze the preventive effect "D-mac 30,000 IU" on postoperative hypocalcemia and safety of 'D-mac 30,000 IU" through a prospective randomized clinical trial.

The incidence of postoperative hypocalcemia of the group taking orally taking vitamin D3 (cholecalciferol) before surgery will be compared with that of the group not taking vitamin D3 before surgery. Patients who are enrolled in this RCT are allocated to the case group and the control group. Patients in the case group are taking 30,000 IU of vitamin D3 (cholecalciferol) orally, and patients in the control group are not taking any drugs.

Primary endpoint of this study is to evaluate the incidence of hypocalcemia. And secondary endpoints are to evaluate the recovery duration from postoperative hypocalcemia and the risk factors for postoperative hypocalcemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Su-jin Kim
        • Sub-Investigator:
          • Jong-hyuk Ahn
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Chung-Ang University Hospital
        • Contact:
        • Principal Investigator:
          • Rayeong Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 19 to 70 years old
  • Patients undergoing total thyroidectomy due to thyroid disease
  • Patients who consented to the study and obtained consent for the study

Exclusion Criteria:

  • Patients with confirmed hypocalcemia or hypercalcemia before surgery
  • Patients receiving calcium or vitamin D treatment before surgery, patients with excessive vitamin D
  • Patients with a previous history of parathyroid disease or a history of cervical irradiation
  • Patients with confirmed parathyroid comorbidity
  • Patients with diseases or conditions that cause hypercalcemia or hypercalciuria (myeloma, bone metastases, or other malignant bone diseases)
  • Patients with confirmed renal dysfunction (glomerular filtration rate <60mL/min/1.73m2) before surgery or with a history of chronic renal failure
  • Renal stone disease patient, kidney stone disease patient
  • Patients with bowel disease that may affect serum vitamin D levels (celiac disease, small intestine resorption disease, small bowel resection history)
  • Patients taking drugs that may affect serum calcium or vitamin D levels (anticonvulsants, bisphosphonates, cisplatin, aminoglycosides, diuretics, proton pump inhibitors, glucocorticoid benzodiazepine derivatives, etc.)
  • Uncontrolled hypertension, diabetes, and clotting disorders
  • Cardiovascular disease (angina pectoris, heart failure, myocardial infarction, coronary artery disease, history of arrhythmia treatment, stroke, transient ischemic attack), and taking medications for arrhythmia
  • Drug Abuse and Alcohol Abuse
  • Patients who participated in other drug clinical trials within 30 days
  • Patients with a history of allergies to drugs
  • For women, pregnant and lactating patients
  • Patients judged unsuitable by the person in charge of the clinical trial
  • Patients with genetic problems such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: case group
One dose of "30,000 IU of D-mac" is taken once 15 days prior to surgery.
Drug: Cholecalciferol

Since the concentration of "D-mac 30,000 IU" in the body reaches the maximum in the body around 1 to 3 weeks after administration, the drug is taken once 15 days before the surgery so that the vitamin D3 concentration is maximized at the time of surgery.

In the case of the control group, there is no drug to be taken.
No Intervention: control group
There is no "30,000 IU of D-mac" to be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hypocalcemia
Time Frame: postoperative 1 day
The incidence of hypocalcemia at postoperative 1 day
postoperative 1 day
Postoperative hypocalcemia
Time Frame: postoperative 2 weeks
The incidence of hypocalcemia at postoperative 2 weeks
postoperative 2 weeks
Postoperative hypocalcemia
Time Frame: postoperative 3 months
The incidence of hypocalcemia at postoperative 3 months
postoperative 3 months
Postoperative hypocalcemia
Time Frame: postoperative 6 months
The incidence of hypocalcemia at postoperative 6 months
postoperative 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of hypocalcemia sign
Time Frame: 1 day, 2 weeks, 3 months, 6 months after surgery
The results of survey about the occurrence of hypocalcemia sign
1 day, 2 weeks, 3 months, 6 months after surgery
Duration of recovery period from postoperative hypocalcemia
Time Frame: 1 day, 2 weeks, 3 months, 6 months after surgery
Duration for recovery from hypocalcemia after thyroidectomy
1 day, 2 weeks, 3 months, 6 months after surgery
Risk factors for developing postoperative hypocalcemia
Time Frame: 1 day, 2 weeks, 3 months, 6 months after surgery
Risk factors associated with postoperative hypocalcemia
1 day, 2 weeks, 3 months, 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Dalim BioTech Co., Ltd.

Investigators

  • Principal Investigator: Su-Jin Kim, M.D., Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2103-050-1203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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