High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
BioTech Pharmacal
Information provided by (Responsible Party):
Sadeq A. Quraishi, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01689779
First received: September 4, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Hypovitaminosis D
Drug: 100, 000 IU cholecalciferol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of High-dose Cholecalciferol Supplementation on Perioperative Vitamin D Status in Colorectal Surgery Patients

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in vitamin D status 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 ] [ Designated as safety issue: Yes ]
    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; 2) 1,25(OH)2D; 3) PTH; 4) DBP; 5) LL37; 6) Albumin; and 7) Calcium levels.


Secondary Outcome Measures:
  • Change in pre-surgical vitamin D status within 24 hours of surgery [ Time Frame: Patients will be followed between the day of surgery and 1 day after surgery ] [ Designated as safety issue: No ]
    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; 2) 1,25(OH)2D; 3) PTH; 4) DBP; 5) LL37; 6) Albumin; and 7) Calcium levels.


Other Outcome Measures:
  • Change in pre-surgical vitamin D status 2 weeks after surgery [ Time Frame: Patients will be followed between the day of surgery and an average duration of 14 days after surgery ] [ Designated as safety issue: No ]
    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; 2) 1,25(OH)2D; 3) PTH; 4) DBP; 5) LL37; 6) Albumin; and 7) Calcium levels.

  • Incidence of short-term post-surgical complications [ Time Frame: Patients will be followed between the day of surgery and an average of 30 days after surgery ] [ Designated as safety issue: No ]
    The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term post-surgical complications within 30 days after surgery. To assess the incidence of post-surgical complications, we will measure rates of: 1) anastomotic leak; 2) pneumonia; 3) urinary tract infection; 4) surgical site infection; 5) sepsis/bacteremia; and 6) mortality


Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cholecalciferol
40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery.
Drug: 100, 000 IU cholecalciferol
Other Name: vitamin D3
Placebo Comparator: Sugar pill
40 patients will receive a sugar pill orally 3-7 days before surgery.
Drug: Placebo
sugar pill

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689779

Contacts
Contact: Livnat Blum, BA lblum@partners.org
Contact: Caitlin McCarthy, BA cmccarthy22@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Sadeq A Quraishi, MD, MHA         
Sub-Investigator: Carlos A Camargo, Jr, MD, DrPH         
Sub-Investigator: David L Berger, MD         
Sponsors and Collaborators
Massachusetts General Hospital
BioTech Pharmacal
Investigators
Principal Investigator: Sadeq A Quraishi, MD, MHA Massachusetts General Hospital
  More Information

No publications provided

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
Study First Received: September 4, 2012
Last Updated: November 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
vitamin D
surgery
acute stress

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

ClinicalTrials.gov processed this record on September 18, 2014