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LL-37

Cathelicidin, hCAP-18, FALL-39, CAP-18

Quick Stats
Studies 2230
Trials 95
Completed PHASE3 INTERVENTIONAL NCT01689779

High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: 100,000 IU cholecalciferol
Type: DRUG
Description: active drug
Name: Placebo
Type: DRUG
Description: comparator drug

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
Description: 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
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
Description: 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

Trial Information

NCT ID

NCT01689779

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Massachusetts General Hospital

Last Updated

December 15, 2025