Vitamin D DeficiencyEarly Phase 1NCT03151174
Effects of Vitamin D Supplementation on Strength, Bone Density, and Injury Risk in Collegiate Athletes
A Early Phase 1 study testing Vitamin D 10000 UNT and Vitamin D 5000 UNT in people with Vitamin D Deficiency, run by Virginia Polytechnic Institute and State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D 10000 UNT and Vitamin D 5000 UNT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2017to 1 Jun 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- athlete for a sanctioned Virginia Tech sport
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D 10000 UNT, Vitamin D 5000 UNT
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 10000 UNTDrug
10000 IU Vitamin D per day
Vitamin D 5000 UNTDrug
5000 IU Vitamin D per day
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D - 10000IU | Experimental | These individuals have been categorized as Vitamin D deficient and will receive 10000IU of Vitamin D per day. Receives: 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. Receives: Drug: Vitamin D 5000 UNT |
| Placebo | No intervention | These individuals have been categorized as Vitamin D sufficient and will receive placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 weeks
Secondary outcomes (3)
Femur Bone Density
Bone Density will be assessed in spine using Dual Energy X-ray Absorptiometry. T-scores will be determined.
Measured: 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.
Measured: 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
Measured: Every week for up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start29 Apr 2017
- Primary completion15 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will either receive placebo, 5000IU, or 10000IU per day of Vitamin D for 8-12 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Hulver, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151174
- Sponsor's protocol ID
- 17-009
- Status last verified
- Oct 2024
- First submitted
- 1 May 2017
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D, Strength, and Bone Density in Collegiate Athletes
- ClinicalTrials.gov ID
- NCT03151174
- Acronym / sponsor ID
- 17-009
- Conditions
- Vitamin D Deficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 29 Apr 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will either receive placebo, 5000IU, or 10000IU per day of Vitamin D for 8-12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D - 10000IU | Experimental | Drug: Vitamin D 10000 UNTThese individuals have been categorized as Vitamin D deficient and will receive 10000IU of Vitamin D per day. |
| Vitamin D - 5000IU | Experimental | Drug: Vitamin D 5000 UNTThese individuals have been categorized as Vitamin D insufficient and will receive 5000IU of Vitamin D per day. |
| Placebo | No intervention | –These individuals have been categorized as Vitamin D sufficient and will receive placebo. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- athlete for a sanctioned Virginia Tech sport
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D 10000 UNT10000 IU Vitamin D per day | Drug | Vitamin D - 10000IU |
| Vitamin D 5000 UNT5000 IU Vitamin D per day | Drug | Vitamin D - 5000IU |
Primary outcome
Strength
Time frame: Up to 12 weeks
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).
3 secondary outcomes
Femur Bone Density
Time frame: Up to 12 weeks
Spine Bone Density
Time frame: Up to 12 weeks
Injury Occurence
Time frame: Every week for up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Hulver, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D 10000 UNT and Vitamin D 5000 UNT in people with Vitamin D Deficiency, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.