Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients

• Status: Suspended
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York City Health and Hospitals Corporation
• Collaborators: Foundation of Orthopedic Trauma; Montefiore Medical Center
• Treatments: Ergocalciferols; Vitamin D

Criteria

Inclusion Criteria:

1. Males and females age 18-65 years

2. One or more orthopaedic injuries on admission

3. Admission injury severity score (ISS)≥16

4. Anticipated stay in hospital of more than 7 days

Exclusion Criteria:

1. Pregnancy (if patient becomes pregnant during the study, she will be removed from the study)

2. End stage kidney disease

3. Patients on furosemide, thiazide, or corticosteroid therapy

4. Patients with chronic liver disease

5. Patients with recent history of vitamin D supplementation more than 5000 IU/day

6. Patients actively undergoing chemo- or immunotherapy

7. Patients with hematologic and solid malignancies

8. Patients receiving treatment for osteoporosis

9. Patients with "nothing per mouth" status secondary to any preceding procedures involving their GI system (e.g. patients with colectomy performed on this admission secondary to gunshot wound to abdomen)