Aerobic Fitness (VO2max)Phase 4VDAFNCT02278172
The Effects of Vitamin D Supplementation on Aerobic Fitness in Athletes
A Phase 4 study testing Vitamin D in people with Aerobic Fitness (VO2max), run by University of Ulster at 1 site in United Kingdom.
Trial summary
The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max in athletes. Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle function, lung function, body composition, immune function and the self-reported incidence of upper respiratory tract… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aerobic Fitness (VO2max)
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Apr 2015
- Phase
- Phase 4
- 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
- Athletes whose sport does not primarily consist of an anaerobic component
- Apparently healthy
- Over the age of 18
Who cannot join
- Resting arterial hypertension
- Individuals who are not an athlete at a University/local sports team
- Athletes who predominantly utilise anaerobic energy systems
- Athletes under the age of 18
- Those that have consumed a supplement containing vitamin D (greater than 400IU/day) or iron supplements for up to 30 days prior to starting the study
- Those with health conditions identified by the screening questionnaire
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- Individuals that are on prescribed medication that is known to affect vitamin D metabolism
- Those following a vegan diet
- Those with a physical disability that would prevent successful completion of the exercise test
- Those who have either had a sun holiday in the 4 weeks prior to starting the study
- Those planning a sun holiday during the intervention period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit (HISU), University of Ulster
Coleraine, Londonderry, BT52 1SA
About this study
Official title: The Effects of Vitamin D Supplementation on VO2max in Athletes: a Randomised, Double-blind, Placebo-controlled Trial
The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max in athletes.
Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle function, lung function, body composition, immune function and the self-reported incidence of upper respiratory tract infection.
This double-blind, randomised, placebo-controlled trial is of parallel design and will aim to recruit a total of 50 athletes randomised into either a placebo or treatment group for a 12-week intervention.
- Conditions
- Aerobic Fitness (VO2max)
- Being tested
- Vitamin D, Placebo
- Keywords
- vitamin D, athletes, fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called cholecalciferol, vitamin D3
3000IU (75 μg) vitamin D in a commercially available oral spray solution
PlaceboDietary supplement
Placebo oral spray solution manufactured to mimic the vitamin D oral spray
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 3000IU (75μg) | Active comparator | Treatment solution delivered via oral spray once daily for 12-weeks Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Placebo solution delivered via oral spray once daily for 12-weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic fitness (VO2max)
A medical screening questionnaire will be completed prior to the test. Athletes resting blood pressure will be measured twice to rule out resting hypertension. After a standardised warm-up, starting speed will be 8/km/hr at 1% incline, until 17/km/hr, after which incline will increase by 1% every minute until VO2max is met. A metabolic cart (Metalyzer 3B) will measure the athlete's ventilation (oxygen uptake and carbon dioxide output) throughout the test.
The test will be terminated when two of the following criterion are met*:
Respiratory exchange ratio reaches/exceeds 1.15 AND VO2 plateau observed OR Heart rate within 10bpm of age-predicted maximum
- Except when volitional exhaustion occurs Athletes will be asked to refrain from strenuous activity for 24 hours prior to VO2max testing in order to control for last bout effects.
Post-exercise lactate concentration (age and gender adjusted) will further-verify that VO2max was attained using a Lactate Pro device.
Measured: At baseline and at 12-weeks
Secondary outcomes (9)
Hand grip strength
Hand grip dynamometry will be used to assess athletes grip strength. This will be measured on both dominant and non-dominant hands three times. The athlete will be asked to hold the device and grip as tightly as possible whilst holding the device alongside their body. There will be a 10 second rest period between measurements.
Measured: At baseline and at 12-weeks
Vertical jump height
Athletes will be asked to reach upwards as far as possible, from a standing position and mark this point on a wall. After this they will be asked to perform a counter-movement jump a total of 3 times with a 10 second rest-period between jumps, reaching as high as possible and making a mark each time. Vertical jump height is calculated from the difference between standing reach height and the best height reached when performing a counter-movement jump.
Measured: At baseline and at 12-weeks
Lung function
Forced expiratory volume at 1 second (FEV1) and forced vital capacity (FVC) will be measured. A calibrated Carefusion® MicroLab portable spirometer will be used to measure these variables.The athletes will need to take a maximal inhalation and then perform a full exhalation as fast as possible into a disposable mouthpiece.
This procedure will be repeated three times and an average taken at each time-point. The timing of repeats will be at the athletes discretion.
Measured: At baseline and at 12-weeks
Nutrient intake
Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire at one time point (baseline only). This is due to studies highlighting equivocal variation in dietary vitamin D intake throughout the year.
24hr recalls will be completed at baseline and at 12-weeks in order to derive mean nutrient intakes for the vitamin D and placebo treatment groups respectively.
Measured: At baseline only/ at baseline and at 12-weeks
Self-reported upper respiratory illness
An online questionnaire will allow athletes to record if they have any symptoms that are associated with upper respiratory infections. The athlete will be asked to mark a series of boxes to indicate how many symptom(s) if any that they have had each week.
Measured: Once per week up to week 12
Physical activity levels
The 'Modified Recent Physical Activity Questionnaire' produced by the Medical Research Council (a validated physical activity questionnaire) will be completed on two occasions to estimate physical activity levels.
Measured: At baseline and at 12-weeks
Body composition
Body composition will be measured using the BodPod, employing air plethysmography (displacement of air) to accurately measure percentage fat mass and percentage fat-free mass.
Measured: At baseline and at 12-weeks
Vitamin D status
25-hydroxyvitamin D (25(OH)D) will be quantified, in serum, using liquid chromatography-tandem mass spectrometry (LCMS/MS). Other biomarkers of vitamin D metabolism (adjusted calcium and parathyroid hormone) will be quantified using a clinical chemistry analyser and commercially available enzyme-linked immunosorbent assay.
Measured: At baseline and at 12-weeks
Immune function
A range of immune markers such as interleukin-6, cathelicidin (LL-37) and C-reactive protein will be measured using a commercially available multiplex immunoassay.
Measured: At baseline and at 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic Fitness (VO2max)Studies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ireland Executive
- Responsible party
- Principal investigator, Dr Pamela Magee, University of Ulster
- Investigators
- Pamela J Magee, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278172
- Sponsor's protocol ID
- REC14.0087
- Acronym
- VDAF
- Status last verified
- May 2016
- First submitted
- 27 Oct 2014
- Last updated
- 25 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin D Supplementation on VO2max in Athletes: a Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02278172
- Acronym / sponsor ID
- VDAF / REC14.0087
- Conditions
- Aerobic Fitness (VO2max)
- Keywords
- vitamin D, athletes, fitness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Northern Ireland Executive
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Oct 2014 (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 primary aim of the study is to identify if vitamin D3 supplementation influences VO2max in athletes.
Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle function, lung function, body composition, immune function and the self-reported incidence of upper respiratory tract infection.
This double-blind, randomised, placebo-controlled trial is of parallel design and will aim to recruit a total of 50 athletes randomised into either a placebo or treatment group for a 12-week intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 3000IU (75μg) | Active comparator | Dietary Supplement: Vitamin DTreatment solution delivered via oral spray once daily for 12-weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo solution delivered via oral spray once daily for 12-weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Athletes whose sport does not primarily consist of an anaerobic component
- Apparently healthy
- Over the age of 18
Key exclusion criteria (11 listed)
- Resting arterial hypertension
- Individuals who are not an athlete at a University/local sports team
- Athletes who predominantly utilise anaerobic energy systems
- Athletes under the age of 18
- Those that have consumed a supplement containing vitamin D (greater than 400IU/day) or iron supplements for up to 30 days prior to starting the study
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: cholecalciferol, vitamin D33000IU (75 μg) vitamin D in a commercially available oral spray solution | Dietary supplement | Vitamin D3 3000IU (75μg) |
| PlaceboPlacebo oral spray solution manufactured to mimic the vitamin D oral spray | Dietary supplement | Placebo |
Primary outcome
Aerobic fitness (VO2max)
Time frame: At baseline and at 12-weeks
A medical screening questionnaire will be completed prior to the test. Athletes resting blood pressure will be measured twice to rule out resting hypertension. After a standardised warm-up, starting speed will be 8/km/hr at 1% incline, until 17/km/hr, after which incline will increase by 1% every minute until VO2max is met. A metabolic cart (Metalyzer 3B) will measure the athlete's ventilation (oxygen uptake and carbon dioxide output) throughout the test. The test will be terminated when two of the following criterion are met*: Respiratory exchange ratio reaches/exceeds 1.15 AND VO2 plateau observed OR Heart rate within 10bpm of age-predicted maximum * Except when volitional exhaustion occurs Athletes will be asked to refrain from strenuous activity for 24 hours prior to VO2max testing in order to control for last bout effects. Post-exercise lactate concentration (age and gender adjusted) will further-verify that VO2max was attained using a Lactate Pro device.
9 secondary outcomes
Hand grip strength
Time frame: At baseline and at 12-weeks
Vertical jump height
Time frame: At baseline and at 12-weeks
Lung function
Time frame: At baseline and at 12-weeks
Nutrient intake
Time frame: At baseline only/ at baseline and at 12-weeks
Self-reported upper respiratory illness
Time frame: Once per week up to week 12
Physical activity levels
Time frame: At baseline and at 12-weeks
Body composition
Time frame: At baseline and at 12-weeks
Vitamin D status
Time frame: At baseline and at 12-weeks
Immune function
Time frame: At baseline and at 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 25 May 2016.
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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.
Pamela J Magee, PhD principal investigator
University of Ulster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Aerobic Fitness (VO2max), run by University of Ulster at 1 site in United Kingdom.
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 3 inclusion and 11 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 May 2016. 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 Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Aerobic fitness (VO2max) (time frame: At baseline and at 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 25 May 2016.