Effects of Vitamin D Supplementation on Strength, Bone Density, and Injury Risk in Collegiate Athletes

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D, Strength, and Bone Density in Collegiate Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151174
• Other study ID #: 17-009
• Status: Completed
• Phase: Early Phase 1
• Start date: April 29, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine whether Vitamin D supplementation improves strength and bone density, and reduces the risk of injury in collegiate athletes.

Description:

Vitamin D is a hormone that is important for bone and muscle health. As such, not having enough vitamin D in your body is associated with increased risk of injury and reduced health and athletic performance. It is often recommended that individuals who have low levels of vitamin D take vitamin D supplements. However, the effects of vitamin D supplementation on health and strength gains in collegiate athletes are not known. The goal of this study is to determine whether vitamin D supplementation increases strength and bone density, while reducing the risk of injury in collegiate athletes. Fasting vitamin D concentrations will be measured and athletes will be supplemented daily with Vitamin D for 8-12 weeks. The amount of supplementation will depend on whether the athlete is categorized as sufficient (>30ng/ml), insufficient (20-35ng/ml), or deficient (<20ng/ml). Vitamin D concentrations, strength, bone density, and injury risk will be assessed before and after the intervention period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 1, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• athlete for a sanctioned Virginia Tech sport

Exclusion Criteria:

• pregnant or trying to become pregnant, currently taking vitamin D (>600IU/day), calcium (>1000mg/dl), taking any performance enhancing supplements (example, creatine), or any other medication or nutritional supplements that might influence the study variables, cardiac or thyroid problems, have diabetes, or epilepsy

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D 10000 UNT
10000 IU Vitamin D per day
• Vitamin D 5000 UNT
5000 IU Vitamin D per day

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength	Overall strength assessed via maximal strength testing. The specific tests may include the following, 1) one repetition max bench press (lbs) -, 2) one repetition max squat (lbs), 3) vertical jump test (feet), 4) broad jump test (feet), 5) dead lifts (lbs and repetition), 6) pull ups (repetition), 7) dips (repetition), and 8) shuttle time (test involving repeated sprints to and from marked points or lines - minutes/ seconds).	Up to 12 weeks
Secondary	Femur Bone Density	Bone Density will be assessed in spine using Dual Energy X-ray Absorptiometry. T-scores will be determined.	Up to 12 weeks
Secondary	Spine Bone Density	Bone Density will be assessed in the hip (proximal femur) using Dual Energy X-ray Absorptiometry. T-scores will be determined.	Up to 12 weeks
Secondary	Injury Occurence	New and current Injuries including bone breaks, muscle strains and sprains will be tracked via a questionnaire that will be filled out weekly. Subjects will report whether they had an injury, where the injury occurred on the body, the type of injury, as well as the date/ time of the injury and how the injury occurred.; Number of injury	Every week for up to 12 weeks