Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes
Primary Purpose
Vitamin D Deficiency, Stress Fracture, Athletic Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cholecalciferol (Vitamin D3)
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
- Athlete on one of the following teams at local University: Men/Women Track and Field, Soccer, Basketball, and Women's Cross Country.
Exclusion Criteria:
- Athlete currently diagnosed with a stress fracture
- Athlete recovering from a lower extremity musculoskeletal injury
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment: Cholecalciferol (Vitamin D3)
Prospective Control Group
Arm Description
Athletes with Vitamin D levels lower than 30ng/mL will be treated with the supplement for eight weeks.
Athletes with Vitamin D levels higher than 30ng/mL were enrolled and compared but not treated.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03395171
First Posted
December 22, 2017
Last Updated
January 3, 2018
Sponsor
Prisma Health-Midlands
1. Study Identification
Unique Protocol Identification Number
NCT03395171
Brief Title
Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes
Official Title
Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2015 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
July 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Midlands
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Stress Fracture, Athletic Injuries, Orthopedic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment: Cholecalciferol (Vitamin D3)
Arm Type
Experimental
Arm Description
Athletes with Vitamin D levels lower than 30ng/mL will be treated with the supplement for eight weeks.
Arm Title
Prospective Control Group
Arm Type
No Intervention
Arm Description
Athletes with Vitamin D levels higher than 30ng/mL were enrolled and compared but not treated.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol (Vitamin D3)
Intervention Description
Supplementation of subjects who meet the inclusion criteria and test to have below the threshold of vitamin D in their blood.
Primary Outcome Measure Information:
Title
Incidence and prevalence of stress fractures in athlete cohorts
Description
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.
Time Frame
5 Years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Athlete on one of the following teams at local University: Men/Women Track and Field, Soccer, Basketball, and Women's Cross Country.
Exclusion Criteria:
Athlete currently diagnosed with a stress fracture
Athlete recovering from a lower extremity musculoskeletal injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Benjamin Jackson III, MD
Organizational Affiliation
Prisma Health-Midlands
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes
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