High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

Mass General Brigham

Status and phase

Completed

Phase 3

Conditions

Hypovitaminosis D

Treatments

Drug: Placebo

Drug: 100,000 IU cholecalciferol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01689779

2012P001852

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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