Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes

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.

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Key information

Conditions

Vitamin D Deficiency Athletic Injuries Avitaminosis Deficiency Diseases Fractures, Bone Fractures, Stress Malnutrition Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Orthopedic Disorder Stress Fracture Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Prisma Health-Midlands

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jan 10, 2018
Registry last updated: Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.

Completed