NCT01689779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 28, 2017

Completed
Last Updated

September 28, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

September 4, 2012

Results QC Date

March 28, 2017

Last Update Submit

August 29, 2017

Conditions

Hypovitaminosis D

Keywords

vitamin Dsurgeryacute stress

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery

    Patients will be followed between the day of surgery and 1 day after surgery

  • Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery

    Patients will be followed between the day of surgery and 1 day after surgery

Other Outcomes (2)

  • Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery

    Patients will be followed between the day of surgery and an average duration of 14 days after surgery

  • Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery

    Patients will be followed between the day of surgery and an average duration of 14 days after surgery

Study Arms (2)

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.

Drug: 100,000 IU cholecalciferol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

100,000 IU cholecalciferolDRUG

active drug

Also known as: vitamin D3
Cholecalciferol
PlaceboDRUG

comparator drug

Also known as: sugar pill
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women;
  • years or older;
  • Scheduled for elective (non-emergent) colorectal surgery;
  • Cleared for anesthesia; and
  • Expected to stay overnight following surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolSugars

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsCarbohydrates

Limitations and Caveats

A small sample size and a relatively homogenous patient cohort at a major teaching hospital limit the generalizability of results.

Results Point of Contact

Title
Sadeq A. Quraishi, MD
Organization
Massachusetts General Hospital
squraishi@mgh.harvard.edu
617-726-3030

Study Officials

  • Sadeq A Quraishi, MD, MHA

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anaesthesia, Harvard Medical School

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 21, 2012

Study Start

January 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 28, 2017

Results First Posted

September 28, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)