FractureNCT04564625
Relationships Between Vitamin D and Orthopedic Trauma
An observational study of Fracture and Fracture Nonunion, run by Methodist Health System at 1 site in United States.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture, Fracture Nonunion, Fractures, Bone
- What is being tested?
- Vitamin D Assessment and Fracture
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to 26 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Patients aged >25yrs
- Prisoners
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Health System Clinical Research Institute
Dallas, Texas, 75203
About this study
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.
Read the detailed description
- 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.
- 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.
- Conditions
- Fracture, Fracture Nonunion, Fractures, Bone, Vitamin D
- Being tested
- Vitamin D Assessment, Fracture
- Keywords
- fracture, fracture nonunion, vitamin D
- Medical subject headings
- Fractures, Bone, Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D AssessmentOther
index admission vitamin D assessment
FractureOther
rate of nonunion (i.e., failure of a fractured bone to heal)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Vitamin D Assessment; Other: Fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: February 2016 and February 2020
Secondary outcomes (7)
Patient demographics
age, sex, ethnicity
Measured: February 2016 and February 2020
injury characteristics
injury characteristics
Measured: February 2016 and February 2020
rate of nonunion
failure of a fractured bone to heal
Measured: February 2016 and February 2020
admit information
admit information
Measured: February 2016 and February 2020
discharge disposition
discharge disposition
Measured: February 2016 and February 2020
payer type
payer type
Measured: February 2016 and February 2020
mortality
mortality
Measured: February 2016 and February 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start6 Mar 2020
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edgar Araiza, MD, Principal investigator, Methodist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564625
- Sponsor's protocol ID
- 005.TRA.2020.D
- Status last verified
- May 2026
- First submitted
- 21 Sep 2020
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
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.
PubMed 30850077Ramirez 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.
PubMed 30317468McClean 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.
PubMed 12868700Lorentzon 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.
PubMed 10770213Ensrud 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.
PubMed 10491209
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Vitamin D and Orthopedic Trauma
- ClinicalTrials.gov ID
- NCT04564625
- Acronym / sponsor ID
- 005.TRA.2020.D
- Conditions
- Fracture, Fracture Nonunion, Fractures, Bone, Vitamin D
- Keywords
- fracture, fracture nonunion, vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fracture and Vitamin D assessment | – | Other: Vitamin D Assessment, Other: FractureAll 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients aged >25yrs
- Prisoners
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D Assessmentindex admission vitamin D assessment | Other | Fracture and Vitamin D assessment |
| Fracturerate of nonunion (i.e., failure of a fractured bone to heal) | Other | Fracture and Vitamin D assessment |
Primary outcome
Vitamin D levels at the time of the index injury through one year post-operative follow up.
Time frame: February 2016 and February 2020
Vitamin D levels at the time of the index injury through one year post-operative follow up.
7 secondary outcomes
Patient demographics
Time frame: February 2016 and February 2020
injury characteristics
Time frame: February 2016 and February 2020
rate of nonunion
Time frame: February 2016 and February 2020
admit information
Time frame: February 2016 and February 2020
discharge disposition
Time frame: February 2016 and February 2020
payer type
Time frame: February 2016 and February 2020
mortality
Time frame: February 2016 and February 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 30850077Horan 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.
- Background: PubMed 30317468Ramirez 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.
- Background: PubMed 12868700McClean 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.
- Background: PubMed 10770213Lorentzon 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.
- Background: PubMed 10491209Ensrud 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar Araiza, MD principal investigator
Methodist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture and Fracture Nonunion, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D levels at the time of the index injury through one year post-operative follow up. (time frame: February 2016 and February 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564625, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.