Phase 2
N=102
Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing
Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02786498 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Fracture Healing Will be Assessed Clinically Using Function IndeX for Trauma (FIX-IT) — 10.1; 9.7; 9.3; 9.0 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D3 (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fracture Healing Will be Assessed Clinically Using Function IndeX for Trauma (FIX-IT) |
10.1; 9.7; 9.3; 9.0 | — |
| PRIMARY Fracture Healing Will be Assessed Radiographically Using Radiographic Union Score for Tibial Fractures (RUST) |
11.0; 11.3; 11.0; 10.4 | — |
| PRIMARY Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker (BTM) C-terminal Telopeptide of Type I Collagen (CTX) |
0.59; 0.79; 0.67; 0.78 | — |
| PRIMARY Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker N-terminal Propeptide of Type I Procollagen (P1NP) |
160.9; 187.8; 166.7; 140.7 | — |
| SECONDARY Serum Level of 25(OH)D |
18.8; 20.7; 19.7; 17.3; 39.3; 38.4 | — |
| SECONDARY Number of Participants With Adherence With Vitamin D Supplementation |
19; 20; 18; 22; 21; 19 | — |
| SECONDARY Number of Participants With Adverse Events (AE) |
9; 10; 11; 14 | — |
| SECONDARY Serum Levels of Calcium |
9.1; 8.8; 8.3; 9.0; 9.6; 9.6 | — |
| SECONDARY Serum Levels of Parathyroid Hormone |
69.6; 64.7; 67.8; 60.3; 41.9; 28.8 | — |
| SECONDARY Count of Participants Who Completed Blood Measures |
26; 24; 24; 26; 21; 20 | — |
| SECONDARY Count of Participants Who Completed Radiographic Imaging Measures |
27; 24; 24; 27; 24; 22 | — |
Summary
The objective is to determine the effect of vitamin D3 supplementation on fracture healing at 3 months.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02786498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.