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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395171
• Other study ID #: Pro00048420
• Status: Completed
• Phase: N/A
• First received: December 22, 2017
• Last updated: January 3, 2018
• Start date: November 30, 2015
• Est. completion date: July 1, 2016

Study information

• Verified date: January 2018
• Source: Palmetto Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Athletic Injuries
• Fractures, Bone
• Fractures, Stress
• Musculoskeletal Diseases
• Orthopedic Disorder
• Stress Fracture
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Cholecalciferol (Vitamin D3)
Supplementation of subjects who meet the inclusion criteria and test to have below the threshold of vitamin D in their blood.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Palmetto Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 Years