Vitamin D DeficiencyNCT03395171
Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes
A study testing Cholecalciferol (Vitamin D3) in people with Vitamin D Deficiency and Stress Fracture, run by Prisma Health-Midlands.
Trial summary
The main objective of this study is to find a correlation between vitamin D deficiency and stress fracture occurrences in athletes who participate in high-risk activities. These high-risk athletes undergo elevated bone turnover, which requires adequate levels of vitamin D in order to support bone health. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Stress Fracture, Athletic Injuries
- What is being tested?
- Cholecalciferol (Vitamin D3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2015to 1 Jul 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Athlete on one of the following teams at local University: Men/Women Track and Field, Soccer, Basketball, and Women's Cross Country.
Who cannot join
- Athlete currently diagnosed with a stress fracture
- Athlete recovering from a lower extremity musculoskeletal injury
About this study
The main objective of this study is to find a correlation between vitamin D deficiency and stress fracture occurrences in athletes who participate in high-risk activities. These high-risk athletes undergo elevated bone turnover, which requires adequate levels of vitamin D in order to support bone health. It is hypothesized that providing supplemental treatment to athletes showing lower than normal serum vitamin D levels will decrease the occurrence of stress fractures. By recording the dates and specific occurrences of fractures, it may be possible to correlate injury rates with seasons, providing more supportive data to pre-existing literature.
This area of research is lacking in the quantity of prospective studies. Previous studies primarily focus on adolescent, elder, or military recruit populations. While literature has shown that vitamin D plays an important role in bone health, there are no previous studies that directly examine vitamin D deficiency and supplemental treatment in conditioned collegiate athlete populations. This study will add to the existing knowledge and will provide a more specific analysis for athletes.
Read the detailed description
This study will focus on athletes who are at a higher risk of lower extremity stress fractures. Specifically, this study will be looking at male and female athletes on the track, cross-country, soccer, and basketball teams at the University of South Carolina. During the pre-season physical of each student athlete, serum vitamin D levels will be taken and recorded. There will be a certified nurse to draw the blood samples. This will take place at the University of South Carolina Athletic Department and/or the Palmetto Health Lab at 2 Medical Park. Potentially, every athlete of the given teams will be enrolled in the study unless they choose not to. Only subjects showing concentrations below 30 ng/mL, which is indicative of insufficient or deficient levels, will be provided supplemental treatment of 25-(OH) vitamin D. Every enrolled subject will be monitored for injury throughout the season. Any and all injuries will be positively identified, and any confirmed stress fractures will be recorded. Data from prospective seasons will be compared to an incidence percentage of athletes from previous seasons. Previous athletes did not receive any vitamin D treatment. These will be used as a control to determine if treatment affected the occurrence of stress fractures. All physicals and tests will be performed at the University of South Carolina Sports Medicine clinic by the sports medicine staff.
- Being tested
- Cholecalciferol (Vitamin D3)
- Medical subject headings
- Vitamin D Deficiency, Fractures, Stress, Athletic Injuries, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (Vitamin D3)Dietary supplement
Supplementation of subjects who meet the inclusion criteria and test to have below the threshold of vitamin D in their blood.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Cholecalciferol (Vitamin D3) | Experimental | Athletes with Vitamin D levels lower than 30ng/mL will be treated with the supplement for eight weeks. Receives: Dietary Supplement: Cholecalciferol (Vitamin D3) |
| Prospective Control Group | No intervention | Athletes with Vitamin D levels higher than 30ng/mL were enrolled and compared but not treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and prevalence of stress fractures in athlete cohorts
To compare the incidence and prevalence of student athletes experiencing stress fractures during the 2015-16 academic year with the five previous years of reported data.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start30 Nov 2015
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Midlands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Benjamin Jackson III, MD, Principal investigator, Prisma Health-Midlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395171
- Sponsor's protocol ID
- Pro00048420
- Status last verified
- Jan 2018
- First submitted
- 22 Dec 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes
- ClinicalTrials.gov ID
- NCT03395171
- Acronym / sponsor ID
- Pro00048420
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Prisma Health-MidlandsUniversity, hospital or other
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 10 Jan 2018 (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.
The main objective of this study is to find a correlation between vitamin D deficiency and stress fracture occurrences in athletes who participate in high-risk activities. These high-risk athletes undergo elevated bone turnover, which requires adequate levels of vitamin D in order to support bone health. It is hypothesized that providing supplemental treatment to athletes showing lower than normal serum vitamin D levels will decrease the occurrence of stress fractures. By recording the dates and specific occurrences of fractures, it may be possible to correlate injury rates with seasons, providing more supportive data to pre-existing literature.
This area of research is lacking in the quantity of prospective studies. Previous studies primarily focus on adolescent, elder, or military recruit populations. While literature has shown that vitamin D plays an important role in bone health, there are no previous studies that directly examine vitamin D deficiency and supplemental treatment in conditioned collegiate athlete populations. This study will add to the existing knowledge and will provide a more specific analysis for athletes.
Detailed description
This study will focus on athletes who are at a higher risk of lower extremity stress fractures. Specifically, this study will be looking at male and female athletes on the track, cross-country, soccer, and basketball teams at the University of South Carolina. During the pre-season physical of each student athlete, serum vitamin D levels will be taken and recorded. There will be a certified nurse to draw the blood samples. This will take place at the University of South Carolina Athletic Department and/or the Palmetto Health Lab at 2 Medical Park. Potentially, every athlete of the given teams will be enrolled in the study unless they choose not to. Only subjects showing concentrations below 30 ng/mL, which is indicative of insufficient or deficient levels, will be provided supplemental treatment of 25-(OH) vitamin D. Every enrolled subject will be monitored for injury throughout the season. Any and all injuries will be positively identified, and any confirmed stress fractures will be recorded. Data from prospective seasons will be compared to an incidence percentage of athletes from previous seasons. Previous athletes did not receive any vitamin D treatment. These will be used as a control to determine if treatment affected the occurrence of stress fractures. All physicals and tests will be performed at the University of South Carolina Sports Medicine clinic by the sports medicine staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment: Cholecalciferol (Vitamin D3) | Experimental | Dietary Supplement: Cholecalciferol (Vitamin D3)Athletes with Vitamin D levels lower than 30ng/mL will be treated with the supplement for eight weeks. |
| Prospective Control Group | No intervention | –Athletes with Vitamin D levels higher than 30ng/mL were enrolled and compared but not treated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Athlete on one of the following teams at local University: Men/Women Track and Field, Soccer, Basketball, and Women's Cross Country.
Key exclusion criteria (2 listed)
- Athlete currently diagnosed with a stress fracture
- Athlete recovering from a lower extremity musculoskeletal injury
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 |
|---|---|---|
| Cholecalciferol (Vitamin D3)Supplementation of subjects who meet the inclusion criteria and test to have below the threshold of vitamin D in their blood. | Dietary supplement | Treatment: Cholecalciferol (Vitamin D3) |
Primary outcome
Incidence and prevalence of stress fractures in athlete cohorts
Time frame: 5 Years
To compare the incidence and prevalence of student athletes experiencing stress fractures during the 2015-16 academic year with the five previous years of reported data.
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 10 Jan 2018.
- Individual participant dataSharing planned: No
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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.
J. Benjamin Jackson III, MD principal investigator
Prisma Health-Midlands
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol (Vitamin D3) in people with Vitamin D Deficiency and Stress Fracture, run by Prisma Health-Midlands.
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 1 inclusion and 2 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence and prevalence of stress fractures in athlete cohorts (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2018.