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Completed

NCT Number: NCT01689779

High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

100,000 IU cholecalciferol

Drug

active drug

Other names: vitamin D3

Placebo

Drug

comparator drug

Other names: sugar pill

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

Secondary outcomes

  1. Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery

    Time frame: Patients will be followed between the day of surgery and 1 day after surgery

    The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.

  2. Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery

    Time frame: Patients will be followed between the day of surgery and 1 day after surgery

    The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.

Other outcomes

  1. Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery

    Time frame: Patients will be followed between the day of surgery and an average duration of 14 days after surgery

    The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.

  2. Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery

    Time frame: Patients will be followed between the day of surgery and an average duration of 14 days after surgery

    The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Bio-Tech Pharmacal, Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2012
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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