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

Primary Purpose

Total Thyroidectomy, Hypocalcemia, Vitamin D Deficiency

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Total Thyroidectomy

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung-Ang University Hospital
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

case group

control group

Arm Description

One dose of "30,000 IU of D-mac" is taken once 15 days prior to surgery.

There is no "30,000 IU of D-mac" to be taken.

Outcomes

Primary Outcome Measures

Postoperative hypocalcemia
The incidence of hypocalcemia at postoperative 1 day
Postoperative hypocalcemia
The incidence of hypocalcemia at postoperative 2 weeks
Postoperative hypocalcemia
The incidence of hypocalcemia at postoperative 3 months
Postoperative hypocalcemia
The incidence of hypocalcemia at postoperative 6 months

Secondary Outcome Measures

The occurrence of hypocalcemia sign
The results of survey about the occurrence of hypocalcemia sign
Duration of recovery period from postoperative hypocalcemia
Duration for recovery from hypocalcemia after thyroidectomy
Risk factors for developing postoperative hypocalcemia
Risk factors associated with postoperative hypocalcemia

Full Information

First Posted
May 10, 2021
Last Updated
April 11, 2023
Sponsor
Seoul National University Hospital
Collaborators
Dalim BioTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05216419
Brief Title
Prevention of Postoperative Hypocalcemia of Oral Vitamin D Supplementation Before Total Thyroidectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Dalim BioTech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Thyroidectomy, Hypocalcemia, Vitamin D Deficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
case group
Arm Type
Experimental
Arm Description
One dose of "30,000 IU of D-mac" is taken once 15 days prior to surgery.
Arm Title
control group
Arm Type
No Intervention
Arm Description
There is no "30,000 IU of D-mac" to be taken.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative hypocalcemia
Description
The incidence of hypocalcemia at postoperative 1 day
Time Frame
postoperative 1 day
Title
Postoperative hypocalcemia
Description
The incidence of hypocalcemia at postoperative 2 weeks
Time Frame
postoperative 2 weeks
Title
Postoperative hypocalcemia
Description
The incidence of hypocalcemia at postoperative 3 months
Time Frame
postoperative 3 months
Title
Postoperative hypocalcemia
Description
The incidence of hypocalcemia at postoperative 6 months
Time Frame
postoperative 6 months
Secondary Outcome Measure Information:
Title
The occurrence of hypocalcemia sign
Description
The results of survey about the occurrence of hypocalcemia sign
Time Frame
1 day, 2 weeks, 3 months, 6 months after surgery
Title
Duration of recovery period from postoperative hypocalcemia
Description
Duration for recovery from hypocalcemia after thyroidectomy
Time Frame
1 day, 2 weeks, 3 months, 6 months after surgery
Title
Risk factors for developing postoperative hypocalcemia
Description
Risk factors associated with postoperative hypocalcemia
Time Frame
1 day, 2 weeks, 3 months, 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Su-jin Kim, M.D., Ph.D.
Phone
+82-2-2072-7208
Email
su.jin.kim.md@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-Jin Kim, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rayeong Song
Email
rayeong_s@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rayeong Song
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su-jin Kim
Email
su.jin.kim.md@gmail.com
First Name & Middle Initial & Last Name & Degree
Su-jin Kim
First Name & Middle Initial & Last Name & Degree
Jong-hyuk Ahn

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21510801
Citation
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Results Reference
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
24402815
Citation
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Results Reference
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PubMed Identifier
24067388
Citation
Alshahrani F, Aljohani N. Vitamin D: deficiency, sufficiency and toxicity. Nutrients. 2013 Sep 13;5(9):3605-16. doi: 10.3390/nu5093605.
Results Reference
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PubMed Identifier
26050997
Citation
Lee GH, Ku YH, Kim HI, Lee MC, Kim MJ. Vitamin D level is not a predictor of hypocalcemia after total thyroidectomy. Langenbecks Arch Surg. 2015 Jul;400(5):617-22. doi: 10.1007/s00423-015-1311-1. Epub 2015 Jun 9.
Results Reference
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Citation
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Citation
Khan Bhettani M, Rehman M, Ahmed M, Altaf HN, Choudry UK, Khan KH. Role of pre-operative vitamin D supplementation to reduce post-thyroidectomy hypocalcemia; Cohort study. Int J Surg. 2019 Nov;71:85-90. doi: 10.1016/j.ijsu.2019.08.035. Epub 2019 Sep 5.
Results Reference
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PubMed Identifier
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Citation
Malik MZ, Mirza AA, Farooqi SA, Chaudhary NA, Waqar M, Bhatti HW. Role of Preoperative Administration of Vitamin D and Calcium in Postoperative Transient Hypocalcemia after Total Thyroidectomy. Cureus. 2019 Apr 30;11(4):e4579. doi: 10.7759/cureus.4579.
Results Reference
result

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

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