Vitamin D DeficiencyPhase 3D-statusNCT02008201
Vitamin D Status and Supplementation in Athletes
A Phase 3 study testing vitamin D in people with Vitamin D Deficiency, run by Wageningen University at 1 site in Netherlands.
Trial summary
The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the effect that supplementation may have during the course of a year. The study is a double blinded parallel study design. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Apr 2014
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- athletes
- 19-60y
Who cannot join
- subjects who take vitamin D supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Status and Supplementation in Elite Athletes
The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the effect that supplementation may have during the course of a year.
The study is a double blinded parallel study design.
Read the detailed description
Study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety of sport disciplines
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D
- Keywords
- dose-response study
- 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 DDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D dose 1 | Experimental | Vitamin D dose 1 Receives: Dietary Supplement: vitamin D |
| Vitamin D dose 2 | Experimental | Vitamin D dose 2 Receives: Dietary Supplement: vitamin D |
| Vitamin D dose 3 | Experimental | Vitamin D dose 3 Receives: Dietary Supplement: vitamin D |
| observational | No intervention | No dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum 25(OH)D
Measured: Every 3 months during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2014
- Study completionApr 2014
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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisette de Groot, Prof. Dr., Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008201
- Sponsor's protocol ID
- D-status
- Acronym
- D-status
- Status last verified
- Dec 2013
- First submitted
- 10 Sep 2013
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status and Supplementation in Elite Athletes
- ClinicalTrials.gov ID
- NCT02008201
- Acronym / sponsor ID
- D-status / D-status
- Conditions
- Vitamin D Deficiency
- Keywords
- dose-response study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Dec 2013 (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.
The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the effect that supplementation may have during the course of a year.
The study is a double blinded parallel study design.
Detailed description
Study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety of sport disciplines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D dose 1 | Experimental | Dietary Supplement: vitamin DVitamin D dose 1 |
| Vitamin D dose 2 | Experimental | Dietary Supplement: vitamin DVitamin D dose 2 |
| Vitamin D dose 3 | Experimental | Dietary Supplement: vitamin DVitamin D dose 3 |
| observational | No intervention | –No dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- athletes
- 19-60y
Key exclusion criteria (1 listed)
- subjects who take vitamin D supplements
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 | Dietary supplement | Vitamin D dose 1, Vitamin D dose 2, Vitamin D dose 3 |
Primary outcome
Change in serum 25(OH)D
Time frame: Every 3 months during one year
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 Dec 2014.
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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.
Lisette de Groot, Prof. Dr. principal investigator
Wageningen University
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 Vitamin D Deficiency, run by Wageningen University at 1 site in Netherlands.
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 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 Dec 2014. 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 Netherlands. 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?
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?
Change in serum 25(OH)D (time frame: Every 3 months during one year). 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 Dec 2014.