Effect of Vitamin D3 Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double-Blind Controlled Trial.

Nearly half of adult fracture patients are vitamin D deficient (serum 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Many surgeons advocate prescribing vitamin D supplements to improve fracture healing outcomes; however, data supporting the effectiveness of vitamin D3 supplements to improve acute fracture healing are lacking. We tested the effectiveness of vitamin D3 supplementation for improving tibia and femur fracture healing. We conducted a single-center, double-blinded phase II screening randomized controlled trial with a 12-month follow-up. Patients aged 18-50 years receiving an intramedullary nail for a tibia or femoral shaft fracture were randomized 1:1:1:1 to receive (i) 150,000 IU loading dose vitamin D3 at injury and 6 weeks (n = 27); (ii) 4000 IU vitamin D3 daily (n = 24); (iii) 600 IU vitamin D3 daily (n = 24); or (iv) placebo (n = 27). Primary outcomes were clinical fracture healing (Function IndeX for Trauma [FIX-IT]) and radiographic fracture healing (Radiographic Union Score for Tibial fractures [RUST]) at 3 months. One hundred two patients with a mean age of 29 years (standard deviation 8) were randomized. The majority were male (69%), and 56% were vitamin D3 deficient at baseline. Ninety-nine patients completed the 3-month follow-up. In our prespecified comparisons, no clinically important or statistically significant differences were detected in RUST or FIX-IT scores between groups when measured at 3 months and over 12 months. However, in a post hoc comparison, high doses of vitamin D3 were associated with improved clinical fracture healing relative to placebo at 3 months (mean difference [MD] 0.90, 80% confidence interval [CI], 0.08 to 1.79; p = 0.16) and within 12 months (MD 0.89, 80% CI, 0.05 to 1.74; p = 0.18). The study was designed to identify potential evidence to support the effectiveness of vitamin D3 supplementation in improving acute fracture healing. Vitamin D3 supplementation, particularly high doses, might modestly improve acute tibia or femoral shaft fracture healing in healthy adults, but confirmatory studies are required. The Vita-Shock trial was awarded the Orthopaedic Trauma Association's (OTA) Bovill Award in 2020. This award is presented annually to the authors of the most outstanding OTA Annual Meeting scientific paper. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Ground Level Falls in Patients Over 60, Do Race and Socioeconomic Status Affect Outcome?

BACKGROUND: Falls are a significant source of morbidity, mortality, and health care spending in the elderly. The objective was to identify whether race, insurance status, and median income by zip code were associated with discharge disposition, readmission within 90 days, or mortality within 1 year of ground-level falls in patients aged 60-90. MATERIALS AND METHODS: We conducted a retrospective chart review of 926 patients aged 60-90 treated for ground-level falls. We created a binomial linear regression model to identify predictors of discharge disposition, 90-day readmission, and mortality within 1 year of discharge. RESULTS: Length of stay (P < .01), having orthopedic surgery (P < .01), score on Charlson Comorbidity Index (CCI) (P < .01), increasing age (P = .014), female sex (P = .05), and admission to the ICU (P = .05) were associated with discharge to a secondary facility. Readmission within 90 days was only associated with higher scores on the CCI (P < .01). Charlson Comorbidity Index (P < .0001), hospital length of stay (P < .001), and admission to the ICU (P = .015) were associated with increased mortality at 1 year. DISCUSSION: Predictors of discharge to another facility included hospital length of stay, having orthopedic surgery, CCI scores, increasing age, female sex, and admission to the ICU. Charlson Comorbidity Index score was the only significant predictor of readmission. Predictors of mortality at 1-year post-fall included CCI score, hospital length of stay, and admission to the ICU. Race, median income by zip code, and insurance provider were not statistically significant.

Patient preferences for nutritional supplementation to improve fracture healing: a discrete choice experiment.

OBJECTIVE: Vitamin D is often prescribed as an adjuvant therapy to aid fracture healing due to its biological role in bone health. However, the optimal frequency, dosage and duration of vitamin D supplementation for non-osteoporotic fracture healing has not been established. The objective of this study was to determine patient preferences for fracture healing relative to hypothetical vitamin D supplementation dosing options. DESIGN: Discrete choice experiment. SETTING: Level 1 trauma centre in Baltimore, Maryland, USA. PARTICIPANTS: 199 adult (18-60 years) patients with a fracture. PRIMARY OUTCOME MEASURES: Parameter estimates of utility for fracture healing relative to dosing regimens were analysed using hierarchical Bayesian modelling. RESULTS: A reduced risk of reoperation (34.3%) and reduced healing time (24.4%) were the attributes of greatest relative importance. The highest mean utility estimates were for a one-time supplementation dose (ß=0.71, 95% CI 0.41 to 1.00) followed by a reduced risk of reoperation (ß=0.41 per absolute % reduction, 95% CI 0.0.36 to 0.46). Supplementation for 24 weeks in duration (ß=-0.83, 95% CI -1.00 to -0.67) and a daily supplement (ß=-0.29, 95% CI -0.47 to -0.11) had the lowest mean utilities. The 'no supplement' option had a large negative value suggesting supplementation was generally desirable in this sample population. Among other possible clinical scenarios, patients expected a 2% reduction in the absolute risk of reoperation or a 3.1-week reduction in healing time from the baseline to accept a treatment regimen requiring two separate doses of supplementation, two blood tests and a cost of $20 within 3 months of injury. CONCLUSIONS: Patients with orthopaedic trauma demonstrated strong willingness to take a vitamin D supplement that would decrease risk of reoperation and reduce healing time. Furthermore, these findings specify the required decrease in reoperation risk and reduction in healing time patients would expect to adhere to possible vitamin D dosing regimens.