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Vitamin D is an essential hormone involved in bone metabolism, bone mineral density maintenance, and bone health. Vitamin D deficiency is putatively linked to poor pediatric orthopedic outcomes [1]. Further, the risk of low vitamin D associated fractures may be greater in minority pediatric populations [2]. In adults, utility of vitamin D alleles as a biomarker for bone density and fracture risk has been debated for over 10 years [3-5]. Peak bone density is achieved at 25 years old; however, most orthopedic trauma patients less than 25 years of age present with substantial vitamin D deficiencies.
INTRODUCTION 1.1. Background Vitamin D is an essential hormone involved in bone metabolism, bone mineral density maintenance, and bone health. Vitamin D deficiency is putatively linked to poor pediatric orthopedic outcomes [1]. Further, the risk of low vitamin D associated fractures may be greater in minority pediatric populations [2]. In adults, utility of vitamin D alleles as a biomarker for bone density and fracture risk has been debated for over 10 years [3-5]. Peak bone density is achieved at 25 years old; however, most orthopedic trauma patients less than 25 years of age present with substantial vitamin D deficiencies.
1.2. Aim(s)
1.3. Rationale for the study Occurrence of stress and low energy mechanism fractures within a population at peak bone density is troubling and suggestive of underlying pathology. Understanding how to combat vitamin D deficiency, and improve outcomes, is essential in the development of comprehensive and preventative trauma care.
1.4. Hypothesis 1.4.1. Primary Hypothesis Patients aged ≤25yrs old with fractures will have low vitamin-D levels.
OBJECTIVES AND STUDY OUTCOME MEASURES 2.1. Study Objectives 2.1.1. Primary Objective Determine the frequency of vitamin D deficiency in fracture patients aged less than 25 years old.
2.1.2. Secondary Objective Report the long-term (one year) outcomes for fracture healing relative to baseline and therapeutic vitamin D levels.
2.2. Study Outcome Measures 2.2.1. Primary Outcome Vitamin D levels at the time of the index injury through one year post-operative follow up.
2.2.2. Secondary Outcomes Patient demographics (age, sex, ethnicity), injury characteristics, lab values, rate of nonunion (i.e., failure of a fractured bone to heal), admit information, discharge disposition, payer type, and mortality.
STUDY DESIGN All patients between 18 and 25 years treated for fractures at Methodist Dallas Medical Center (MDMC) with an index admission vitamin D assessment will be enrolled. This study will consider any patients with an index admission occurring between February 2016 and February 2020. No changes to care or intervention will occur and this study will be conducted completely via chart review. The aim is to identify 100 subjects with a one-year follow-up appointment for their injury to determine the rate of nonunion and vitamin D levels. As patients receive vitamin D supplementation as standard of care if index values are low, impact will be assessed through relative deficiency and clinical outcomes. Data collected from subjects without need for supplementation may be used to generate a threshold. Patient demographics will be considered as practice suggests minority patients may be disproportionally affected. The plan to complete the data collection and analysis by February 2021.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fracture and Vitamin D assessment | All patients between 18 and 25 years treated for fractures at Methodist Dallas Medical Center (MDMC) with an index admission vitamin D assessment will be enrolled. This study will consider any patients with an index admission occurring between February 2016 and February 2020. No changes to care or intervention will occur and this study will be conducted completely via chart review. The aim is to identify 100 subjects with a one-year follow-up appointment for their injury to determine the rate of nonunion and vitamin D levels. As patients receive vitamin D supplementation as standard of care if index values are low, impact will be assessed through relative deficiency and clinical outcomes. Data collected from subjects without need for supplementation may be used to generate a threshold. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D Assessment | Other | index admission vitamin D assessment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D levels at the time of the index injury through one year post-operative follow up. | Vitamin D levels at the time of the index injury through one year post-operative follow up. | February 2016 and February 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | age, sex, ethnicity | February 2016 and February 2020 |
| injury characteristics | injury characteristics | February 2016 and February 2020 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients between 18 and 25 years treated for fractures at Methodist Dallas Medical Center (MDMC) with an index admission vitamin D assessment will be enrolled. This study will consider any patients with an index admission occurring between February 2016 and February 2020.We will also consider patient demographics as practice suggests minority patients may be disproportionally affected.
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| Name | Affiliation | Role |
|---|---|---|
| Edgar Araiza, MD | Methodist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Health System Clinical Research Institute | Dallas | Texas | 75203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30850077 | Background | Horan MP, Williams K, Hughes D. The Role of Vitamin D in Pediatric Orthopedics. Orthop Clin North Am. 2019 Apr;50(2):181-191. doi: 10.1016/j.ocl.2018.10.002. | |
| 30317468 | Background | Ramirez N, Ortiz-Fullana JL, Arciniegas N, Fullana A, Valentin P, Orengo JC, Iriarte I, Carlo S. Vitamin D levels and fracture risk among Hispanic children. Eur J Orthop Surg Traumatol. 2019 Apr;29(3):531-536. doi: 10.1007/s00590-018-2315-7. Epub 2018 Oct 13. |
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This is a single center study and the data will not be shared with outside entities until it is de-identified in order to be presented at relevant conferences or published in a scientific journal
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D005599 | Fractures, Ununited |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Fracture |
| Other |
rate of nonunion (i.e., failure of a fractured bone to heal) |
|
| rate of nonunion | failure of a fractured bone to heal | February 2016 and February 2020 |
| admit information | admit information | February 2016 and February 2020 |
| discharge disposition | discharge disposition | February 2016 and February 2020 |
| payer type | payer type | February 2016 and February 2020 |
| mortality | mortality | February 2016 and February 2020 |
| 12868700 | Background | McClean E, Archbold GP, Taggart HM. Do the COL1A1 and Taq 1 vitamin D receptor polymorphisms have a role in identifying individuals at risk of developing osteoporosis? Ulster Med J. 2003 May;72(1):26-33. |
| 10770213 | Background | Lorentzon M, Lorentzon R, Nordstrom P. Vitamin D receptor gene polymorphism is associated with birth height, growth to adolescence, and adult stature in healthy caucasian men: a cross-sectional and longitudinal study. J Clin Endocrinol Metab. 2000 Apr;85(4):1666-70. doi: 10.1210/jcem.85.4.6566. |
| 10491209 | Background | Ensrud KE, Stone K, Cauley JA, White C, Zmuda JM, Nguyen TV, Eisman JA, Cummings SR. Vitamin D receptor gene polymorphisms and the risk of fractures in older women. For the Study of Osteoporotic Fractures Research Group. J Bone Miner Res. 1999 Oct;14(10):1637-45. doi: 10.1359/jbmr.1999.14.10.1637. |