Phase 3
N=60
High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status
Hypovitaminosis D
Bottom Line
View on ClinicalTrials.gov: NCT01689779 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol — 8; -2 percent change in 25(OH)D
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 100,000 IU cholecalciferol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol |
8; -2 | — |
| PRIMARY Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol |
-10; -5 | — |
| SECONDARY Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery |
-5; -4 | — |
| SECONDARY Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery |
-3; -5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01689779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.