Relationships Between Vitamin D and Orthopedic Trauma (NCT04564625) | Clinical Trial Compass
CompletedNot Applicable
Relationships Between Vitamin D and Orthopedic Trauma
United States100 participantsStarted 2020-03-06
Plain-language 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.
Who can participate
Age range
18 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tracked vitamin D levels in fracture patients for up to a year after surgery — based on findings like these, should I have my vitamin D levels tested now that I've had a fracture, and what level would you consider concerning?
2The study looked at the relationship between vitamin D and fracture nonunion, which means a bone that doesn't heal properly — is there anything in my situation that makes me more at risk for nonunion, and would checking my vitamin D help address that risk?
3Since this trial is already completed, has the data from it changed how you approach vitamin D monitoring or supplementation for patients recovering from fractures like mine?
4If my vitamin D turns out to be low, would you recommend supplementation as part of my fracture recovery plan, and is there evidence from studies like this one that it could make a meaningful difference in my healing?
5Are there standard-of-care steps my treatment team already takes to check and manage vitamin D after an orthopedic injury, or is this still something only being studied in research settings?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vitamin D levels at the time of the index injury through one year post-operative follow up.