Vitamin D StatusNCT02858882
Vitamin D Status and Muscle Function
An observational study of Vitamin D Status and Muscle Function, run by University of Copenhagen.
Trial summary
People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due to low sun exposure and the risk may be even more pronounced among elite swimmers since indoor training further reduces sun exposure. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status, Muscle Function
- What is being tested?
- Screening
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Apr 2007
- Phase
- Observational
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 16-35 years
- Top atlets, conducting:
- Hard physical activity
- Indoor elitesport min. 10 hours a week
- Healthy, without use of any medications
- Eat fish max 2 times per week
Who cannot join
- Use of corticosteroids
- Illness
- Use of supplements
- Use of solarium
- Donation of blood within the last 3 months
- Having spent time below the latitude of 42° north from September through April
About this study
Official title: Vitamin D Status and Muscle Function Among Adolescent and Young Swimmers.
People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due to low sun exposure and the risk may be even more pronounced among elite swimmers since indoor training further reduces sun exposure. In light of this, the investigators want to examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength.
Read the detailed description
To examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength, twenty-nine swimmers, 12 female and 17 male (16-24 years) residing at latitude 55-56°N were included to the trial conducted in March-April. Blood samples were analysed for serum 25-hydroxyvitamin D (s-25(OH)D) and hand-grip strength was measured as marker of muscle strength. Subjects´ vitamin D and calcium intake were assessed by food frequency questionnaire and sun exposure and training status by questionnaires.
- Conditions
- Vitamin D Status, Muscle Function
- Being tested
- Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Screening of elite swimmers
| Study group | Role | What they receive |
|---|---|---|
| Swimmers | Screening of elite athletes Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxyvitamin D (s-25(OH)D)
Measured: 2 months
Secondary outcomes (2)
Food frequency questionnaire
Measured: One week
Hand-grip strength
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startFeb 2007
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D StatusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Team Denmark, Hvidovre University Hospital, Danmarks Fødevareforskning, Bispebjerg Hospital
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858882
- Sponsor's protocol ID
- KF01322182
- Status last verified
- Oct 2016
- First submitted
- 27 Jul 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status and Muscle Function Among Adolescent and Young Swimmers.
- ClinicalTrials.gov ID
- NCT02858882
- Acronym / sponsor ID
- KF01322182
- Conditions
- Vitamin D Status, Muscle Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Team Denmark, Hvidovre University Hospital, Danmarks Fødevareforskning, Bispebjerg Hospital
- Study start
- Feb 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 8 Aug 2016 (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.
People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due to low sun exposure and the risk may be even more pronounced among elite swimmers since indoor training further reduces sun exposure. In light of this, the investigators want to examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength.
Detailed description
To examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength, twenty-nine swimmers, 12 female and 17 male (16-24 years) residing at latitude 55-56°N were included to the trial conducted in March-April. Blood samples were analysed for serum 25-hydroxyvitamin D (s-25(OH)D) and hand-grip strength was measured as marker of muscle strength. Subjects´ vitamin D and calcium intake were assessed by food frequency questionnaire and sun exposure and training status by questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swimmers | – | Other: ScreeningScreening of elite athletes |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age: 16-35 years
- Hard physical activity
- Indoor elitesport min. 10 hours a week
- Healthy, without use of any medications
- Eat fish max 2 times per week
Key exclusion criteria (6 listed)
- Use of corticosteroids
- Illness
- Use of supplements
- Use of solarium
- Donation of blood within the last 3 months
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 |
|---|---|---|
| ScreeningScreening of elite swimmers | Other | Swimmers |
Primary outcome
Serum 25-hydroxyvitamin D (s-25(OH)D)
Time frame: 2 months
2 secondary outcomes
Food frequency questionnaire
Time frame: One week
Hand-grip strength
Time frame: 2 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 27 Oct 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Status and Muscle Function, run by University of Copenhagen.
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 6 inclusion and 6 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Serum 25-hydroxyvitamin D (s-25(OH)D) (time frame: 2 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 27 Oct 2016.