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临床试验/NCT01689779
NCT01689779已完成3 期

Effect of High-dose Cholecalciferol Supplementation on Perioperative Vitamin D Status in Colorectal Surgery Patients

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol

研究概览

简要总结

A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of surgical site infections (SSIs). At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems. The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.

详细描述

While vitamin D insufficiency [25(OH)D <30 ng/mL] is common in the general population, hypovitaminosis D may affect 40-80% of patients in the perioperative setting. Recent evidence also suggests that surgical stress may be associated with a 40% reduction in circulating 25(OH)D levels when compared to preoperative values. Moreover, the derangement in perioperative 25(OH)D levels may be sustained for up to 3 months after surgery. This finding has potential implications regarding modifiable risk factors for surgical site infections (SSIs), which account for nearly 40% of all nosocomial infections. On aggregate, SSIs result in 3.7 million extra hospital days per annum and an added burden of $1.6 billion in annual healthcare costs. A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of SSIs. At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems. Yet, optimization of perioperative vitamin D status remains grossly understudied. Although our overarching aim is to study the impact of vitamin D status on SSIs, the focus of the current investigation is to determine whether the administration of a "bolus" oral dose of cholecalciferol (vitamin D3) in the preoperative setting alters vitamin D status in the perioperative setting (compared to a placebo). The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women;
  • 18 years or older;
  • Scheduled for elective (non-emergent) colorectal surgery;
  • Cleared for anesthesia; and
  • Expected to stay overnight following surgery

排除标准

  • Scheduled for a purely laparoscopic procedure;
  • Diagnosis of a terminal illness and/or in hospice care;
  • Inability to sign informed consent;
  • Inability to comply with study protocol;
  • Intending to start vitamin D supplementation within 30 days of surgery;
  • Intending to leave the Boston area during the follow-up period;
  • History of renal stones or hypercalcemia;
  • Medical conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma primary hyperparathyroidism)
  • History of hypercalcemia
  • History of severe anemia (Hematocrit <25%)
  • Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis medication); and
  • Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings

研究组 & 干预措施

Cholecalciferol

Active Comparator

A maximum of 40 patients will receive a one-time oral dose of 100,000 IU cholecalciferol 3-7 days before their scheduled elective surgery.

干预措施: 100,000 IU cholecalciferol (Drug)

Placebo

Placebo Comparator

A maximum of 40 patients will receive a one-time oral sugar pill 3-7 days before their scheduled elective surgery.

干预措施: Placebo (Drug)

结局指标

主要结局

Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol

时间窗: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37

Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol

时间窗: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37

次要结局

  • Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery(Patients will be followed between the day of surgery and 1 day after surgery)
  • Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery(Patients will be followed between the day of surgery and 1 day after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sadeq A. Quraishi

Assistant Professor of Anaesthesia, Harvard Medical School

Massachusetts General Hospital

研究点 (1)

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