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

NCT03151174 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 17-009
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Femur Bone Density

  Up to 12 weeks

• Spine Bone Density

  Up to 12 weeks

• Injury Occurence

  Every week for up to 12 weeks

Study Arms (3)

Vitamin D - 10000IU

EXPERIMENTAL

These individuals have been categorized as Vitamin D deficient and will receive 10000IU of Vitamin D per day.

Drug: Vitamin D 10000 UNT

Vitamin D - 5000IU

EXPERIMENTAL

These individuals have been categorized as Vitamin D insufficient and will receive 5000IU of Vitamin D per day.

Drug: Vitamin D 5000 UNT

Placebo

NO INTERVENTION

These individuals have been categorized as Vitamin D sufficient and will receive placebo.

Interventions

Vitamin D 10000 UNT DRUG

10000 IU Vitamin D per day

Vitamin D - 10000IU

Vitamin D 5000 UNT DRUG

5000 IU Vitamin D per day

Vitamin D - 5000IU

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• athlete for a sanctioned Virginia Tech sport

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Tech

Blacksburg, Virginia, 24060, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Matthew Hulver, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Any individuals involved in study measures will also be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will either receive placebo, 5000IU, or 10000IU per day of Vitamin D for 8-12 weeks.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 12, 2017
• Study Start: April 29, 2017
• Primary Completion: May 15, 2018
• Study Completion: June 1, 2018
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)