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

Vitamin D, Strength, and Bone Density in Collegiate Athletes

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D 10000 UNT; Drug: Vitamin D 5000 UNT

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Virginia Tech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D - 10000IU; These individuals have been categorized as Vitamin D deficient and will receive 10000IU of Vitamin D per day.	Drug: Vitamin D 10000 UNT; 10000 IU Vitamin D per day
Experimental: Vitamin D - 5000IU; These individuals have been categorized as Vitamin D insufficient and will receive 5000IU of Vitamin D per day.	Drug: Vitamin D 5000 UNT; 5000 IU Vitamin D per day
No Intervention: Placebo; These individuals have been categorized as Vitamin D sufficient and will receive placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Matthew Hulver, PhD, Virginia Polytechnic Institute and State University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2017
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 17-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No