High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Bio-Tech Pharmacal, Inc.
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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