Relationships Between Vitamin D and Orthopedic Trauma

NCT04564625 | Unknown

• 1 other identifier: 005.TRA.2020.D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture; Fracture Nonunion; Fractures, Bone; Vitamin D

Keywords

fracture; fracture nonunion; vitamin D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient demographics

  February 2016 and February 2020

• injury characteristics

  February 2016 and February 2020

• rate of nonunion

  February 2016 and February 2020

• admit information

  February 2016 and February 2020

• discharge disposition

  February 2016 and February 2020

Study Arms (1)

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; Other: Fracture

Interventions

Vitamin D Assessment OTHER

index admission vitamin D assessment

Fracture and Vitamin D assessment

Fracture OTHER

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

Fracture and Vitamin D assessment

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients aged \>25yrs
• Prisoners
• Pregnant

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Health System Clinical Research Institute

Dallas, Texas, 75203, United States

Location

Related Publications (5)

• 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.

  PMID: 30850077 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.

  PMID: 30317468 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.

  PMID: 12868700 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.

  PMID: 10770213 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.

  PMID: 10491209 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Fractures, Ununited

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Edgar Araiza, MD

  Methodist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: March 20, 2023
• Primary Completion: February 20, 2024
• Study Completion: March 20, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)