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Relationships Between Vitamin D and Orthopedic Trauma

Relationships Between Vitamin D and Orthopedic Trauma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04564625
Enrollment
100
Registered
2020-09-25
Start date
2020-03-06
Completion date
2021-02-26
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture, Fracture Nonunion, Fractures, Bone, Vitamin D

Keywords

fracture, fracture nonunion, vitamin D

Brief summary

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.

Detailed description

1. 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) * Identify the prevalence of vitamin D deficiency in young trauma patients with fractures. * Describe the merits of vitamin D supplementation in healing and long-term outcomes ≤25 year old trauma patients with fractures. 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. 2. 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. 3. 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.

Interventions

OTHERVitamin D Assessment

index admission vitamin D assessment

OTHERFracture

rate of nonunion (i.e., failure of a fractured bone to heal)

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients must be \>18 years old and ≤25 years old * Patients must have any fracture requiring follow-up * Patients must have received vitamin-D assessment

Exclusion criteria

* Patients aged \>25yrs * Prisoners * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Vitamin D levels at the time of the index injury through one year post-operative follow up.February 2016 and February 2020Vitamin D levels at the time of the index injury through one year post-operative follow up.

Secondary

MeasureTime frameDescription
Patient demographicsFebruary 2016 and February 2020age, sex, ethnicity
injury characteristicsFebruary 2016 and February 2020injury characteristics
rate of nonunionFebruary 2016 and February 2020failure of a fractured bone to heal
admit informationFebruary 2016 and February 2020admit information
discharge dispositionFebruary 2016 and February 2020discharge disposition
payer typeFebruary 2016 and February 2020payer type
mortalityFebruary 2016 and February 2020mortality

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREdgar Araiza, MD

Methodist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026