## Protocol Section
### Identification Module
**NCT ID:** NCT01689779

**Brief Title:** High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

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

#### Organization Study ID Info
**ID:** 2012P001852
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2015-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-09-28

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-09-28

**Type:** ACTUAL

**Results First Submit Date:** 2017-03-28

**Results First Submit QC Date:** 2017-08-29

#### Start Date
**Date:** 2013-01

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2012-09-21
**Type:** ESTIMATED
**Study First Submit Date:** 2012-09-04
**Study First Submit QC Date:** 2012-09-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Bio-Tech Pharmacal, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Investigator Affiliation:** Massachusetts General Hospital

**Investigator Full Name:** Sadeq A. Quraishi

**Investigator Title:** Assistant Professor of Anaesthesia, Harvard Medical School

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Hypovitaminosis D

**Keywords:**

- vitamin D

- surgery

- acute stress

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: 100,000 IU cholecalciferol

**Label:** Cholecalciferol

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cholecalciferol

**Description:** active drug

**Name:** 100,000 IU cholecalciferol

**Other Names:**

- vitamin D3

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** comparator drug

**Name:** Placebo

**Other Names:**

- sugar pill

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

#### Primary Outcomes

**Description:** 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

**Measure:** 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

**Description:** 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

**Measure:** 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

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital

**State:** Massachusetts

**Zip:** 02114

#### Overall Officials

**Official 1:**

**Affiliation:** Massachusetts General Hospital

**Name:** Sadeq A Quraishi, MD, MHA

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003677

- Term: Deficiency Diseases

- ID: D000044342

- Term: Malnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001851

- Term: Bone Diseases, Metabolic

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000002128

- Term: Calcium Metabolism Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17551

- Name: Vitamin D Deficiency

- Relevance: HIGH

- As Found: Hypovitaminosis D

- ID: M15108

- Name: Rickets

- Relevance: HIGH

- As Found: Hypovitaminosis D

- ID: M4660

- Name: Avitaminosis

- Relevance: HIGH

- As Found: Hypovitaminosis

- ID: M6879

- Name: Deficiency Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25306

- Name: Malnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5130

- Name: Bone Diseases, Metabolic

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5391

- Name: Calcium Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T5019

- Name: Rickets

- Relevance: HIGH

- As Found: Hypovitaminosis D

### Condition Browse Module - Meshes

- ID: D000012279

- Term: Rickets

- ID: D000001361

- Term: Avitaminosis

- ID: D000014808

- Term: Vitamin D Deficiency

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000050071

- Term: Bone Density Conservation Agents

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: HIGH

- As Found: Ultrasound

- ID: M6003

- Name: Cholecalciferol

- Relevance: HIGH

- As Found: 2.5

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: HIGH

- As Found: 2.5

- ID: T479

- Name: Vitamin D3

- Relevance: HIGH

- As Found: Unacceptable

- ID: T440

- Name: Calciferol

- Relevance: HIGH

- As Found: 2.5

### Intervention Browse Module - Meshes

- ID: D000014807

- Term: Vitamin D

- ID: D000002762

- Term: Cholecalciferol

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Cholecalciferol

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 28

**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol

**ID:** EG000

**Other Num at Risk:** 28

**Serious Number At Risk:** 28

**Title:** Cholecalciferol

**Group ID:** EG001

**Title:** Sugar Pill

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 32

**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill

**ID:** EG001

**Other Num at Risk:** 32

**Serious Number At Risk:** 32

**Title:** Sugar Pill

**Frequency Threshold:** 0

**Time Frame:** Data was collected over a period of 30 days post drug administration

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 28

**Group ID:** BG001

**Value:** 32

**Group ID:** BG002

**Value:** 60

**Units:** Participants

### Group

**ID:** BG000

**Title:** Cholecalciferol

**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol

### Group

**ID:** BG001

**Title:** Sugar Pill

**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13

**Value:** 56

#### Measurement

**Group ID:** BG001

**Spread:** 13

**Value:** 61

#### Measurement

**Group ID:** BG002

**Spread:** 13

**Value:** 57

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 34

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 26

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 53

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** A small sample size and a relatively homogenous patient cohort at a major teaching hospital limit the generalizability of results.
### Point of Contact
**Email:** squraishi@mgh.harvard.edu
**Organization:** Massachusetts General Hospital
**Phone:** 617-726-3030
**Title:** Sadeq A. Quraishi, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4
- **Upper Limit:** 
- **Value:** -2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6
- **Upper Limit:** 
- **Value:** -5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4
- **Upper Limit:** 
- **Value:** -4
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17
- **Upper Limit:** 
- **Value:** -10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12
- **Upper Limit:** 
- **Value:** -5
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24
- **Upper Limit:** 
- **Value:** -3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 31
- **Upper Limit:** 
- **Value:** -5
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27
- **Upper Limit:** 
- **Value:** 16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 37
- **Upper Limit:** 
- **Value:** 2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Data are presented as percent change in levels between baseline assessment and day of surgery
**Reporting Status:** POSTED
**Time Frame:** Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
**Title:** Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol
**Type:** PRIMARY
**Unit of Measure:** percent change in 25(OH)D
##### Group
**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol
**ID:** OG000
**Title:** Cholecalciferol
##### Group
**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill
**ID:** OG001
**Title:** Sugar Pill
#### Outcome Measure 2
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Data are presented as percent change in levels between baseline assessment and day after surgery
**Reporting Status:** POSTED
**Time Frame:** Patients will be followed between the day of surgery and 1 day after surgery
**Title:** Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery
**Type:** SECONDARY
**Unit of Measure:** Percent change in 25(OH)D
##### Group
**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol
**ID:** OG000
**Title:** Cholecalciferol
##### Group
**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill
**ID:** OG001
**Title:** Sugar Pill
#### Outcome Measure 3
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery
**Reporting Status:** POSTED
**Time Frame:** Patients will be followed between the day of surgery and an average duration of 14 days after surgery
**Title:** Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Percent change in 25(OH)D
##### Group
**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol
**ID:** OG000
**Title:** Cholecalciferol
##### Group
**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill
**ID:** OG001
**Title:** Sugar Pill
#### Outcome Measure 4
**Description:** 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
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Data are presented as percent change in levels between baseline assessment and day of surgery
**Reporting Status:** POSTED
**Time Frame:** Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
**Title:** Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol
**Type:** PRIMARY
**Unit of Measure:** percent change in LL-37
##### Group
**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol
**ID:** OG000
**Title:** Cholecalciferol
##### Group
**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill
**ID:** OG001
**Title:** Sugar Pill
#### Outcome Measure 5
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Data are presented as percent change in levels between baseline assessment and day after surgery
**Reporting Status:** POSTED
**Time Frame:** Patients will be followed between the day of surgery and 1 day after surgery
**Title:** Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery
**Type:** SECONDARY
**Unit of Measure:** Percent change in LL-37
##### Group
**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol
**ID:** OG000
**Title:** Cholecalciferol
##### Group
**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill
**ID:** OG001
**Title:** Sugar Pill
#### Outcome Measure 6
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery
**Reporting Status:** POSTED
**Time Frame:** Patients will be followed between the day of surgery and an average duration of 14 days after surgery
**Title:** Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Percent change in LL-37
##### Group
**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol
**ID:** OG000
**Title:** Cholecalciferol
##### Group
**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill
**ID:** OG001
**Title:** Sugar Pill
### Participant Flow Module
#### Group
**Description:** 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.

100, 000 IU cholecalciferol
**ID:** FG000
**Title:** Cholecalciferol
#### Group
**Description:** 40 patients will receive a sugar pill orally 3-7 days before surgery.

Placebo: sugar pill
**ID:** FG001
**Title:** Sugar Pill
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 32
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True