Clinical trial NCT01689779: High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status
Official title: Effect of High-dose Cholecalciferol Supplementation on Perioperative Vitamin D Status in Colorectal Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypovitaminosis D
Keywords: vitamin D
surgery
acute stress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Bio-Tech Pharmacal, Inc.
First posted: 2012-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol
timeFrame: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
measure: Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol
timeFrame: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
Secondary outcomes:
measure: Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery
timeFrame: Patients will be followed between the day of surgery and 1 day after surgery
measure: Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery
timeFrame: Patients will be followed between the day of surgery and 1 day after surgery
Other outcomes:
measure: Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery
timeFrame: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
measure: Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery
timeFrame: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sadeq A Quraishi, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References: