Effects of Vitamin D Supplementation on Strength, Bone Density, and Injury Risk in Collegiate Athletes
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D 10000 UNT
Vitamin D 5000 UNT
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin D Deficiency
Eligibility Criteria
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
Sites / Locations
- Virginia Tech
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Vitamin D - 10000IU
Vitamin D - 5000IU
Placebo
Arm Description
These individuals have been categorized as Vitamin D deficient and will receive 10000IU of Vitamin D per day.
These individuals have been categorized as Vitamin D insufficient and will receive 5000IU of Vitamin D per day.
These individuals have been categorized as Vitamin D sufficient and will receive placebo.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Femur Bone Density
Bone Density will be assessed in spine using Dual Energy X-ray Absorptiometry. T-scores will be determined.
Spine Bone Density
Bone Density will be assessed in the hip (proximal femur) using Dual Energy X-ray Absorptiometry. T-scores will be determined.
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
Full Information
NCT ID
NCT03151174
First Posted
May 1, 2017
Last Updated
June 27, 2018
Sponsor
Virginia Polytechnic Institute and State University
1. Study Identification
Unique Protocol Identification Number
NCT03151174
Brief Title
Effects of Vitamin D Supplementation on Strength, Bone Density, and Injury Risk in Collegiate Athletes
Official Title
Vitamin D, Strength, and Bone Density in Collegiate Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 29, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Subjects will either receive placebo, 5000IU, or 10000IU per day of Vitamin D for 8-12 weeks.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Any individuals involved in study measures will also be masked.
Allocation
Non-Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D - 10000IU
Arm Type
Experimental
Arm Description
These individuals have been categorized as Vitamin D deficient and will receive 10000IU of Vitamin D per day.
Arm Title
Vitamin D - 5000IU
Arm Type
Experimental
Arm Description
These individuals have been categorized as Vitamin D insufficient and will receive 5000IU of Vitamin D per day.
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
These individuals have been categorized as Vitamin D sufficient and will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Vitamin D 10000 UNT
Intervention Description
10000 IU Vitamin D per day
Intervention Type
Drug
Intervention Name(s)
Vitamin D 5000 UNT
Intervention Description
5000 IU Vitamin D per day
Primary Outcome Measure Information:
Title
Strength
Description
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).
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Femur Bone Density
Description
Bone Density will be assessed in spine using Dual Energy X-ray Absorptiometry. T-scores will be determined.
Time Frame
Up to 12 weeks
Title
Spine Bone Density
Description
Bone Density will be assessed in the hip (proximal femur) using Dual Energy X-ray Absorptiometry. T-scores will be determined.
Time Frame
Up to 12 weeks
Title
Injury Occurence
Description
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
Time Frame
Every week for up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Hulver, PhD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Tech
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Vitamin D Supplementation on Strength, Bone Density, and Injury Risk in Collegiate Athletes
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