Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients

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.

Conditions

• Vitamin D Deficiency
• Polytrauma
• Orthopedic Disorder

Interventions

DRUG

Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]

50cc of ergocalciferol 8000 IU/ml will be given to participants as a one-time dose.

DRUG

Propylene Glycol

50cc of propylene glycole will be given to participants as one-time dose, used as placebo

Sponsors & Collaborators

• Foundation of Orthopedic Trauma

  collaborator OTHER

• Montefiore Medical Center

  collaborator OTHER

• New York City Health and Hospitals Corporation

  lead OTHER

Principal Investigators

• Milan Sen, MD · Montefiore Medical Center / Jacobi Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2020-03-31

Completion

2020-03-31

FDA Drug

Yes

Countries

• United States

Study Locations