Status:
COMPLETED
Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
McMaster University
Conditions:
Fracture
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The objective is to determine the effect of vitamin D3 supplementation on fracture healing at 3 months.
Detailed Description
Vitamin D supplements are increasingly being recommended to healthy adult fracture patients without an osteoporotic injury. Although this is a relatively new practice pattern, the basis for this adjun...
Eligibility Criteria
Inclusion
- Adult men or women ages 18-50 years
- Closed or low grade open (Gustilo type I or II) tibial or femoral shaft fracture
- Fracture treated with a reamed, locked, intramedullary nail
- Acute fracture (enrolled within 7 days of injury)
- Provision of informed consent.
Exclusion
- Osteoporosis
- Stress fractures
- Elevated serum calcium (\>10.5 mg/dL)
- Atypical femur fractures as defined by American Society for Bone and Mineral Research (ASBMR) criteria
- Pathological fractures secondary to neoplasm or other bone lesion
- Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfecta etc.
- Patients with hyperhomocysteinemia
- Patients with an allergy to vitamin D or another contraindication to being prescribed vitamin D
- Patients currently taking an over the counter multivitamin that contains vitamin D and are unable or unwilling to discontinue its use for this study
- Patients who will likely have problems, in the judgment of the investigators, with maintaining follow-up
- Pregnancy
- Patients who are incarcerated
- Patients who are not expected to survive their injuries
- Other lower extremity injuries that prevent bilateral full weight-bearing by 6 weeks post-fracture.
Key Trial Info
Start Date :
November 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT02786498
Start Date
November 21 2016
End Date
December 1 2021
Last Update
March 31 2022
Active Locations (2)
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1
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
2
McMaster University, Center for Evidence-Based Orthopaedics
Hamilton, Ontario, Canada, L8L 8E7