Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients
Status:
Suspended
Trial end date:
2020-03-01
Target enrollment:
Participant gender:
Summary
Although vitamin D is known to play a major role in multiple organ functions in healthy
adults, including bone homeostasis, its role in the unique population of orthopaedic
polytrauma patients has not been well described. The aim of this therapeutic randomized
placebo-controlled feasibility study is to determine the effect of vitamin D supplementation
initiated on admission on patients' 25(OH)-D level, bone turnover markers, and clinical
outcomes in a cohort of adult orthopaedic polytrauma patients. Polytrauma patients with one
or more orthopaedic injuries admitted to an urban Level I trauma center will be screened for
eligibility based upon strict inclusion and exclusion criteria. Sixty patients meeting the
criteria will be consented, enrolled and randomized in a 1:1 ratio to intervention and
control (placebo) arm. Baseline 25(OH)-D and bone turnover marker levels will be drawn for
all the patients on admission, and the intervention arm will receive a one-time dose of
ergocalciferol (Vitamin D2) 400,000 IU shortly after enrollment. The labs will be repeated 7
days after the initial draw or at discharge, whichever occurs first. Patients' daily
immobilization status, baseline characteristics and clinical outcomes will be recorded.
Statistical methods will be used to assess whether there is a difference in 25(OH)-D and bone
turnover markers levels associated with the intervention.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
New York City Health and Hospitals Corporation
Collaborators:
Foundation of Orthopedic Trauma Montefiore Medical Center