Methodist Health System Clinical Research Institute
Dallas, Texas, 75203, United States
NCT Number: NCT04564625
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.
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Notify Me18 year–25 year
All sexes
Observational
Dallas, Texas, 75203, United States
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
index admission vitamin D assessment
rate of nonunion (i.e., failure of a fractured bone to heal)
Time frame: February 2016 and February 2020
Vitamin D levels at the time of the index injury through one year post-operative follow up.
Time frame: February 2016 and February 2020
age, sex, ethnicity
Time frame: February 2016 and February 2020
injury characteristics
Time frame: February 2016 and February 2020
failure of a fractured bone to heal
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
Methodist Health System
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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