Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients

Mass General Brigham

Status: Withdrawn

Conditions: Hypovitaminosis D

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cholecalciferol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01858051

2013P001071

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Cholecalciferol Bolus Dose

Active Comparator group

Description:

70 patients will receive a bolus pre-operative oral dose of 150,000 IU cholecalciferol 3-7 days before surgery

Treatment:

Dietary Supplement: Cholecalciferol

Cholecalciferol Divided Dose

Active Comparator group

Description:

70 patients will receive an oral 100,000 IU cholecalciferol dose 3-7 days before surgery and an additional oral 50,000 IU cholecalciferol dose on post-operative day 1

Treatment:

Dietary Supplement: Cholecalciferol

Sugar Pill

Placebo Comparator group

Description:

35 patients will receive a placebo pill orally 3-7 days before surgery

Treatment:

Dietary Supplement: Placebo