Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: McMaster University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Adult men or women ages 18-50 years

2. Closed or low grade open (Gustilo type I or II) tibial or femoral shaft fracture

3. Fracture treated with a reamed, locked, intramedullary nail

4. Acute fracture (enrolled within 7 days of injury)

5. Provision of informed consent.

Exclusion Criteria:

1. Osteoporosis

2. Stress fractures

3. Elevated serum calcium (>10.5 mg/dL)

4. Atypical femur fractures as defined by American Society for Bone and Mineral Research (ASBMR) criteria

5. Pathological fractures secondary to neoplasm or other bone lesion

6. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfecta etc.

7. Patients with hyperhomocysteinemia

8. Patients with an allergy to vitamin D or another contraindication to being prescribed vitamin D

9. Patients currently taking an over the counter multivitamin that contains vitamin D and are unable or unwilling to discontinue its use for this study

10. Patients who will likely have problems, in the judgment of the investigators, with maintaining follow-up

11. Pregnancy

12. Patients who are incarcerated

13. Patients who are not expected to survive their injuries

14. Other lower extremity injuries that prevent bilateral full weight-bearing by 6 weeks post-fracture.