Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing

Completed · Phase 2 · Has a placebo group

Conditions studied: Fracture

In brief

The objective is to determine the effect of vitamin D3 supplementation on fracture healing at 3 months.

Key facts

Study ID

NCT02786498

Run by

University of Maryland, Baltimore

People needed

102

Starts

2016-11-21

Expected to finish

2021-12-01

Last updated by the study team

2022-03-31

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• McMaster University, Center for Evidence-Based Orthopaedics — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.