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

NCT03395171 | Completed

• 1 other identifier: Pro00048420
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vitamin D Deficiency; Stress Fracture; Athletic Injuries; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment: Cholecalciferol (Vitamin D3)

EXPERIMENTAL

Athletes with Vitamin D levels lower than 30ng/mL will be treated with the supplement for eight weeks.

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.

Interventions

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.

Treatment: Cholecalciferol (Vitamin D3)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Athlete on one of the following teams at local University: Men/Women Track and Field, Soccer, Basketball, and Women's Cross Country.

You may not qualify if:

• Athlete currently diagnosed with a stress fracture
• Athlete recovering from a lower extremity musculoskeletal injury

Sponsors & Collaborators

• Prisma Health-Midlands: lead

MeSH Terms

Conditions

Vitamin D Deficiency; Fractures, Stress; Athletic Injuries; Musculoskeletal Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• J. Benjamin Jackson III, MD

  Prisma Health-Midlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 10, 2018
• Study Start: November 30, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share