HealthyPhase 3NCT01488227
A Prospective Trial on the Effects of Vitamin D Supplementation in Collegiate Swimmers and Divers
A Phase 3 study testing Vitamin D in people with Healthy, run by University of Kentucky at 1 site in United States.
Trial summary
Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce injuries and illnesses, and improve performance in collegiate swimmers and divers. Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course of the intervention period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University of Kentucky Swimmers and Divers, at least 18 years old.
- No recent history of Vitamin D supplementation beyond 400IU
Who cannot join
- hormone replacement therapy,
- high dose Vitamin D supplementation,
- history of renal disease or kidney stones,
- organ transplantation,
- sarcoidosis,
- parathyroid disease,
- history of high blood calcium levels.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Trial on the Effects of Vitamin D Supplementation on 25(OH)D, Body Composition and Injury in Collegiate Swimmers and Divers
Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce injuries and illnesses, and improve performance in collegiate swimmers and divers.
Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course of the intervention period.
Read the detailed description
The investigators plan to recruit from approximately 45 male and female University of Kentucky Swimmers and Divers, at least 18 years of age in August 2011. Approximately equal numbers of men and women will be recruited. The entire athletic team(s) will be recruited. With a conservative dropout rate of 30%, the investigators final sample size should be approximately 22 participants (per group).Following baseline measures, participants will be randomized to one of two groups (Vitamin D 4000 IU or Placebo control) and monitored over the course of their athletic season. Measurements will be repeated at Midpoint (3 months) and Endpoint (6 months).
Participants will have no recent history of Vitamin D supplementation beyond what is normally found in a multivitamin (400 IUs).
Following the informed consent process a medical history and Vitamin D questionnaire (screenings), and urine pregnancy test (for female athletes) will be administered prior to more invasive baseline testing procedures (blood draw and DXA). A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess Vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, bone turnover markers, and inflammatory cytokines. A Vitamin D lifestyle questionnaire will be administered at all 3 time points and incidence of illness and injury will be documented over 6 months following randomization. DXA measures will only occur at Baseline and Endpoint.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Vitamin D by Nature Made by Pharmavite LLC
4000 IU of Vitamin D daily for 6 months
PlaceboDietary supplement
Also called Placebo by Nature Made by Pharmavite LLC
Acts as a control for the Vitamin D intervention
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Vitamin D Receives: Dietary Supplement: Vitamin D |
| Oil pill | Placebo comparator | Contains vegetable and soybean oil supplied by Nature Made by Pharmavite LLC located in Northridge, CA and is United States Pharmacopeia (USP) certified. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D)
Baseline, Midpoint, and Endpoint measures include a blood draw for 25(OH)D status.
Measured: 3 measurement periods over 6 months
Secondary outcomes (5)
Inflammatory Cytokines
Baselineand Endpoint measures include a blood draw inflammatory cytokines (TNF alpha, IL1-B, IL6)
Measured: Baseline and Enpoint
Bone Turnover Markers
Baseline, Midpoint, and Endpoint measures include a blood draw for bone turnover markers (BSAP, NTx).
Measured: Baseline, Midpoint, Endpoint
DXA Body Composition
Baseline and Endpoint measures include Body Composition measures (DXA) for fat, muscle and bone composition
Measured: Baseline and Endpoint
Vitamin D Lifestyle Survey
Baseline, Midpoint, and Endpoint measures include a behavioral survey for estimating 25(OH)D status (solar exposure, food and other supplemental intake)
Measured: Baseline, Midpoint, Endpoint
injury and illness incidence
We will track injury and illness type and incidence over the course of the 6 month intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maja Redzic, B.S., Study director, University of KentuckyRegina M Lewis, B.S., Study director, University of KentuckyDavid T Thomas, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488227
- Sponsor's protocol ID
- UL1RR033173
- Status last verified
- Feb 2013
- First submitted
- 29 Nov 2011
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial on the Effects of Vitamin D Supplementation on 25(OH)D, Body Composition and Injury in Collegiate Swimmers and Divers
- ClinicalTrials.gov ID
- NCT01488227
- Acronym / sponsor ID
- UL1RR033173
- Conditions
- Healthy
- Keywords
- Vitamin D status in athletes, Vitamin D, 25(OH)D, athletes, body composition, inflammatory markers, illness, injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Dec 2011 (estimated)
- 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.
Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce injuries and illnesses, and improve performance in collegiate swimmers and divers.
Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course of the intervention period.
Detailed description
The investigators plan to recruit from approximately 45 male and female University of Kentucky Swimmers and Divers, at least 18 years of age in August 2011. Approximately equal numbers of men and women will be recruited. The entire athletic team(s) will be recruited. With a conservative dropout rate of 30%, the investigators final sample size should be approximately 22 participants (per group).Following baseline measures, participants will be randomized to one of two groups (Vitamin D 4000 IU or Placebo control) and monitored over the course of their athletic season. Measurements will be repeated at Midpoint (3 months) and Endpoint (6 months).
Participants will have no recent history of Vitamin D supplementation beyond what is normally found in a multivitamin (400 IUs).
Following the informed consent process a medical history and Vitamin D questionnaire (screenings), and urine pregnancy test (for female athletes) will be administered prior to more invasive baseline testing procedures (blood draw and DXA). A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess Vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, bone turnover markers, and inflammatory cytokines. A Vitamin D lifestyle questionnaire will be administered at all 3 time points and incidence of illness and injury will be documented over 6 months following randomization. DXA measures will only occur at Baseline and Endpoint.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin DVitamin D |
| Oil pill | Placebo comparator | Dietary Supplement: PlaceboContains vegetable and soybean oil supplied by Nature Made by Pharmavite LLC located in Northridge, CA and is United States Pharmacopeia (USP) certified. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- University of Kentucky Swimmers and Divers, at least 18 years old.
- No recent history of Vitamin D supplementation beyond 400IU
Key exclusion criteria (7 listed)
- hormone replacement therapy,
- high dose Vitamin D supplementation,
- history of renal disease or kidney stones,
- organ transplantation,
- sarcoidosis,
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 DAlso: Vitamin D by Nature Made by Pharmavite LLC4000 IU of Vitamin D daily for 6 months | Dietary supplement | Vitamin D |
| PlaceboAlso: Placebo by Nature Made by Pharmavite LLCActs as a control for the Vitamin D intervention | Dietary supplement | Oil pill |
Primary outcome
25(OH)D)
Time frame: 3 measurement periods over 6 months
Baseline, Midpoint, and Endpoint measures include a blood draw for 25(OH)D status.
5 secondary outcomes
Inflammatory Cytokines
Time frame: Baseline and Enpoint
Bone Turnover Markers
Time frame: Baseline, Midpoint, Endpoint
DXA Body Composition
Time frame: Baseline and Endpoint
Vitamin D Lifestyle Survey
Time frame: Baseline, Midpoint, Endpoint
injury and illness incidence
Time frame: 6 months
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 25 Feb 2013.
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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.
Maja Redzic, B.S. study director
University of Kentucky
Regina M Lewis, B.S. study director
University of Kentucky
David T Thomas, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Healthy, run by University of Kentucky 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 2 inclusion and 7 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 25 Feb 2013. 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
25(OH)D) (time frame: 3 measurement periods over 6 months). 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 25 Feb 2013.