Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients

NCT01858051 | Withdrawn DMC

• 1 other identifier: 2013P001071
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovitaminosis D

Keywords

Vitamin D; Perioperative immune regulation; LL-37; Hospital-acquired infection; Surgical site infections

Outcome Measures

Primary Outcomes (1)

• Change in vitamin D status 5 days following supplementation with cholecalciferol

  Subjects will receive 150,000 IU or 100,000 IU cholecalciferol (vs. placebo) 3-7 days before surgery during their pre-operative assessment. Vitamin D status on the day of pre-operative assessment will be compared to vitamin D status on the day of surgery. To assess vitamin D status, we will measure serum: 1) 25-hydroxyvitamin D; 2) Parathyroid hormone; 3) Vitamin D binding protein; 4) LL-37; 5) Albumin; and 6) Calcium levels.

  Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

Secondary Outcomes (3)

• Change in pre-surgical vitamin D status 1 day after surgery

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

• Change in pre-surgical vitamin D status 2 weeks after surgery

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

• Change in pre-surgical vitamin D status 3 months after surgery

  Patients will be followed between the day of surgery and an average of 90 days after surgery

Other Outcomes (1)

• Incidence of post-operative complications within 3 months of surgery

  Patients will be followed between the day of surgery and an average of 90 days after surgery

Study Arms (3)

Cholecalciferol Bolus Dose

ACTIVE COMPARATOR

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

Dietary Supplement: Cholecalciferol

Cholecalciferol Divided Dose

ACTIVE COMPARATOR

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

Dietary Supplement: Cholecalciferol

Sugar Pill

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

Cholecalciferol Bolus Dose; Cholecalciferol Divided Dose

Placebo DIETARY_SUPPLEMENT

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bio-Tech Pharmacal, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Cross Infection; Surgical Wound Infection

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wound Infection; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sadeq A Quraishi, MD, MMSc

  Harvard Medical School, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: May 16, 2013
• First Posted: May 20, 2013
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)