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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Postoperative hypocalcemia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
case group
One dose of "30,000 IU of D-mac" is taken once 15 days prior to surgery.
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Postoperative hypocalcemia
时间窗: postoperative 6 months
The incidence of hypocalcemia at postoperative 6 months
次要结局
- Risk factors for developing postoperative hypocalcemia(1 day, 2 weeks, 3 months, 6 months after surgery)
- Duration of recovery period from postoperative hypocalcemia(1 day, 2 weeks, 3 months, 6 months after surgery)
- The occurrence of hypocalcemia sign(1 day, 2 weeks, 3 months, 6 months after surgery)
研究者
Su-jin Kim
Professor
Seoul National University Hospital