Status:
COMPLETED
Prevention of Postoperative Hypocalcemia of Oral Vitamin D Supplementation Before Total Thyroidectomy
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Dalim BioTech Co., Ltd.
Conditions:
Total Thyroidectomy
Hypocalcemia
Eligibility:
All Genders
19-70 years
Phase:
PHASE4
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 convu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05216419
Start Date
June 7 2021
End Date
October 16 2024
Last Update
April 24 2025
Active Locations (2)
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1
Chung-Ang University Hospital
Seoul, South Korea
2
Seoul National University Hospital
Seoul, South Korea