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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
Prisma Health-Midlands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 22, 2017
    Last Updated
    January 3, 2018
    Sponsor
    Prisma Health-Midlands
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    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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