ClinicalTrials.gov
ClinicalTrials.gov Menu

High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01689779
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Bio-Tech Pharmacal, Inc.
Information provided by (Responsible Party):
Sadeq A. Quraishi, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Hypovitaminosis D Drug: 100,000 IU cholecalciferol Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of High-dose Cholecalciferol Supplementation on Perioperative Vitamin D Status in Colorectal Surgery Patients
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: 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.
Drug: 100,000 IU cholecalciferol
active drug
Other Name: vitamin D3

Placebo Comparator: Placebo
A maximum of 40 patients will receive a one-time oral sugar pill 3-7 days before their scheduled elective surgery.
Drug: Placebo
comparator drug
Other Name: sugar pill




Primary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.


Other Outcome Measures:
  1. 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 ]
    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.

  2. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689779


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Bio-Tech Pharmacal, Inc.
Investigators
Principal Investigator: Sadeq A Quraishi, MD, MHA Massachusetts General Hospital

Responsible Party: Sadeq A. Quraishi, Assistant Professor of Anaesthesia, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01689779     History of Changes
Other Study ID Numbers: 2012P001852
First Posted: September 21, 2012    Key Record Dates
Results First Posted: September 28, 2017
Last Update Posted: September 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sadeq A. Quraishi, Massachusetts General Hospital:
vitamin D
surgery
acute stress

Additional relevant MeSH terms:
Avitaminosis
Rickets
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents