Clinical trial NCT01858051: Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients
Official title: Bolus vs. Divided Cholecalciferol Dosing to Optimize Perioperative Vitamin D Status for Joint Replacement Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypovitaminosis D
Keywords: Vitamin D
Perioperative immune regulation
LL-37
Hospital-acquired infection
Surgical site infections
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Bio-Tech Pharmacal, Inc.
First posted: 2013-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the United States, \~1 million elective hip or knee replacement surgeries are performed annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents \~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint replacement surgery. Although SSIs only account for 20% of all HAIs, they are a major risk factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also been identified as an independent risk factor for infections of implanted hardware.

In general, the majority of PJIs become apparent within 3 months of hardware implantation, but deep infections may not be evident for up to one year after surgery. Hardware infections result in delayed healing, repeated surgical interventions, and long-term antibiotic therapy. PJIs are associated with an average increase in hospital LOS by 14 days, additional expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate compared to uninfected lower extremity joint replacements.

Recent work from our group suggests that vitamin D insufficiency may be a risk factor for perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery. To date, perioperative vitamin D optimization strategies have not been reported. Therefore, our goal is to study the effect of a single (pre-operative) versus a divided (pre-operative and on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in patients scheduled for elective hip or knee joint replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age ≥18 years
* English or Spanish speaking
* Scheduled for preoperative clinic assessment
* Scheduled to have elective hip or knee joint replacement surgery
* Not taking more than 1000 IU of either cholecalciferol or ergocalciferol daily

Exclusion Criteria:

* Unable to provide consent
* Inability to comply with study protocol
* History of anemia (hematocrit \<25%)
* History of renal stones or hypercalcemia
* Conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma)
* Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis medication)
* 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

Primary outcomes:
measure: Change in vitamin D status 5 days following supplementation with cholecalciferol
timeFrame: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
Secondary outcomes:
measure: Change in pre-surgical vitamin D status 1 day after surgery
timeFrame: Patients will be followed between the day of surgery and an average duration of 1 day after surgery
measure: Change in pre-surgical vitamin D status 2 weeks after surgery
timeFrame: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
measure: Change in pre-surgical vitamin D status 3 months after surgery
timeFrame: Patients will be followed between the day of surgery and an average of 90 days after surgery
Other outcomes:
measure: Incidence of post-operative complications within 3 months of surgery
timeFrame: Patients will be followed between the day of surgery and an average of 90 days after surgery
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Harvard Medical School, Massachusetts General Hospital
name: Sadeq A Quraishi, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: