High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

NCT ID: NCT01689779

Last Updated: 2017-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-05-31

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.

Conditions

Hypovitaminosis D

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cholecalciferol

A maximum of 40 patients will receive a one-time oral dose of 100,000 IU cholecalciferol 3-7 days before their scheduled elective surgery.

Group Type: ACTIVE_COMPARATOR

100,000 IU cholecalciferol

Intervention Type: DRUG

active drug

Placebo

A maximum of 40 patients will receive a one-time oral sugar pill 3-7 days before their scheduled elective surgery.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

comparator drug

Interventions

100,000 IU cholecalciferol

active drug

Intervention Type: DRUG

Placebo

comparator drug

Intervention Type: DRUG

Other Intervention Names

vitamin D3; sugar pill

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bio-Tech Pharmacal, Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sadeq A. Quraishi

Assistant Professor of Anaesthesia, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sadeq A Quraishi, MD, MHA

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2012P001852

Identifier Type: -

Identifier Source: org_study_id