Relationships Between Vitamin D and Orthopedic Trauma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fractures, Bone; Fracture; Vitamin D; Fracture Nonunion
• Intervention / Treatment: Other: Vitamin D Assessment; Other: Fracture

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Health System Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Vitamin D Assessment; index admission vitamin D assessment; Other: Fracture; rate of nonunion (i.e., failure of a fractured bone to heal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics	age, sex, ethnicity	February 2016 and February 2020
injury characteristics	injury characteristics	February 2016 and February 2020
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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Edgar Araiza, MD, Methodist

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): February 20, 2024
• Study Completion (Estimated): March 20, 2024

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: fracture; vitamin D; fracture nonunion
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Ununited; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 005.TRA.2020.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No