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| Name | Class |
|---|---|
| Bio-Tech Pharmacal, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | A maximum of 40 patients will receive a one-time oral sugar pill 3-7 days before their scheduled elective surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100,000 IU cholecalciferol | Drug | active drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol | 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 | Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days |
| Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol | 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 | Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of 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. | Patients will be followed between the day of surgery and 1 day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks 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. | Patients will be followed between the day of surgery and an average duration of 14 days after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sadeq A Quraishi, MD, MHA | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cholecalciferol | 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol |
| FG001 | Sugar Pill | 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cholecalciferol | 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol |
| BG001 | Sugar Pill | 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol | 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 | Data are presented as percent change in levels between baseline assessment and day of surgery | Posted | Mean | Standard Deviation | percent change in 25(OH)D | Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days |
|
Data was collected over a period of 30 days post drug administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cholecalciferol | 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol |
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A small sample size and a relatively homogenous patient cohort at a major teaching hospital limit the generalizability of results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sadeq A. Quraishi, MD | Massachusetts General Hospital | 617-726-3030 | squraishi@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | comparator drug |
|
|
| Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of 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. | Patients will be followed between the day of surgery and 1 day after surgery |
| Percent (%) Change in Pre-surgical LL-37 2 Weeks 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. | Patients will be followed between the day of surgery and an average duration of 14 days after surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sugar Pill | 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill |
|
|
| Secondary | Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of 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. | Data are presented as percent change in levels between baseline assessment and day after surgery | Posted | Mean | Standard Deviation | Percent change in 25(OH)D | Patients will be followed between the day of surgery and 1 day after surgery |
|
|
|
| Other Pre-specified | Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks 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. | Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery | Posted | Mean | Standard Deviation | Percent change in 25(OH)D | Patients will be followed between the day of surgery and an average duration of 14 days after surgery |
|
|
|
| Primary | Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol | 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 | Data are presented as percent change in levels between baseline assessment and day of surgery | Posted | Mean | Standard Deviation | percent change in LL-37 | Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days |
|
|
|
| Secondary | Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of 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. | Data are presented as percent change in levels between baseline assessment and day after surgery | Posted | Mean | Standard Deviation | Percent change in LL-37 | Patients will be followed between the day of surgery and 1 day after surgery |
|
|
|
| Other Pre-specified | Percent (%) Change in Pre-surgical LL-37 2 Weeks 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. | Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery | Posted | Mean | Standard Deviation | Percent change in LL-37 | Patients will be followed between the day of surgery and an average duration of 14 days after surgery |
|
|
|
| 1 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Sugar Pill | 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill | 1 | 32 | 0 | 32 | 0 | 32 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D002241 | Carbohydrates |