Vitamin DNCT05214027
The Effect of an Acute Bout of Exercise on Serum Vitamin D Concentration
An observational study of Vitamin D and Acute Exercise, run by University of Bath at 1 site in United Kingdom.
Trial summary
Vitamin D deficiency is considered a public health priority in the UK, with approximately 30-40% of the UK population being deemed vitamin D deficient during winter months. Current government strategies to improve vitamin D status amongst the UK population involve dietary supplementation, however, it has been shown… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D, Acute Exercise
- What is being tested?
- Treadmill-Based Exercise (60% VO2 Max for 60 minutes) and Rest (60 minutes)
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 1 Nov 2021
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy, community-dwelling adults (aged 25-65 years old)
Who may be able to join
- Healthy (see exclusion criteria)
- 25-65 years old
- Ability to travel to and from University of Bath campus
Who cannot join
- Current or recent use (within the last three months) of weight loss drugs, medication that would interfere with study outcomes, sunbeds, or dietary vitamin D supplementation
- Change in weight of more than 5% in the last six months, or a significant change in lifestyle in the last two months
- Positive responses to the Physical Activity Readiness Questionnaire (PAR-Q)
- Presence of coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure, peripheral arterial disease, severe hypertension (blood pressure >180/110 mmHg)
- BMI <18kg/m2 or BMI >40kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Vitamin D deficiency is considered a public health priority in the UK, with approximately 30-40% of the UK population being deemed vitamin D deficient during winter months. Current government strategies to improve vitamin D status amongst the UK population involve dietary supplementation, however, it has been shown that excess adiposity reduces the impact of dietary supplementation with vitamin D. One potential explanation for this observation is that vitamin D becomes sequestered in adipose tissue. We hypothesise that exercise may facilitate the mobilisation of vitamin D from adipose tissue and thus increase circulating vitamin D (25OHD) concentrations. Little is currently known as to whether a single bout of exercise affects vitamin D status, with a handful of studies demonstrating contradictory findings. This research will examine the effect of an acute bout of exercise (treadmill-based at 60% VO2 Max for 60 minutes) on vitamin D status (serum 25(OH)D) in healthy community-dwelling adults.
Read the detailed description
This study is a random crossover design and will require 34 participants to visit the University of Bath on 6 separate occasions in total.
Individuals who express an interest in taking part will be invited to attend an initial screening meeting at the University so that the eligibility can be assessed for the study, and the all procedures explained verbally. If the participant is eligible and is happy to participate in the study, they will attend a second visit prior to two trials to undertake a treadmill-based maximal exercise test (VO2 Max), resting metabolic rate measure and several measures will be taken to assess body composition. Trials will involve a 60-minute exercise bout at 60% of the participant's maximum oxygen uptake or a 60-minute resting period (both followed by a further hour of rest). The order in which these trials occur will be randomised for each participant and the participant will not be told of this order prior to the trials.
During both trials, a cannula will be inserted into a vein in the arm prior to exercise and 10ml blood samples will be drawn at baseline (pre-exercise) and immediately after the exercise session and 1 hour post exercise from the antecubital vein. The participant will return to the university the day after each trial for a 10ml venous blood sample (24hr post-exercise) which will be taken via venepuncture. In the 24 hours following a trial, participants will be provided with standardised meals in order to ensure energy balance. Other controls which will be applied during the study period will include the provision of factor 50 sunscreen (if the participant is undertaking trials between March and October) to aid in mitigating against the cutaneous synthesis of vitamin D, and guidance on avoiding any strenuous activity 24 hours prior to trial days. Participants will also be provided with a physical activity monitor (MotionWatch8, CamNTech) to wear during trial days after leaving the lab.
- Conditions
- Vitamin D, Acute Exercise
- Being tested
- Treadmill-Based Exercise (60% VO2 Max for 60 minutes), Rest (60 minutes)
- Keywords
- Vitamin D, Acute Exercise, Adults, United Kingdom, Lipid Mobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill-Based Exercise (60% VO2 Max for 60 minutes)Other
Each participant will undergo a single 60-minute treadmill-based exercise intervention in a randomised order.
Treadmill settings are generated based on settings which correspond to participants exercising at 60% VO2 max from their maximal exercise test on visit 2. To confirm that participants are exercising at 60% during the hour session, 1 minute samples of expired air are taken at 15 minute intervals and immediately analysed to check % VO2 max. Participants heart rate and RPE measures are also taken at 15 minute intervals throughout the exercise session and cross-checked against predicted values at 60% VO2 Max.
Rest (60 minutes)Other
Each participant will undergo a 60-minute rest period in a randomised order.
| Study group | Role | What they receive |
|---|---|---|
| Participants | This study follows a randomised crossover design. All participants will undergo a single 60-minute treadmill-based exercise intervention, and a resting period for equal duration in a randomised order. Receives: Other: Treadmill-Based Exercise (60% VO2 Max for 60 minutes); Other: Rest (60 minutes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum vitamin D concentration
As assessed by serum 25(OH)D via LC-MS
Measured: 24 hours- change from baseline to 24 hours post exercise
Secondary outcomes (3)
Markers of lipid mobilisation
As assessed by plasma NEFA, triacyglycerol and glycerol
Measured: 24 hours- change from baseline to 24 hours post exercise
Calcium
As assessed by serum calcium
Measured: 24 hours- change from baseline to 24 hours post exercise
Other vitamin D metabolites
As assessed by serum 1,25(OH)D and other forms of serum vitamin D via LC-MS
Measured: 24 hours- change from baseline to 24 hours post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Apr 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin DStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Responsible party
- Principal investigator, Sophie Davies, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214027
- Sponsor's protocol ID
- EP 19/20 026
- Status last verified
- Nov 2022
- First submitted
- 12 Jan 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davies SE, Perkin OJ, Betts JA, Gonzalez JT, Hewison M, Jenkinson C, Jones KS, Meadows SR, Parkington DA, Koulman A, Thompson D. The effect of an acute bout of exercise on circulating vitamin D metabolite concentrations: a randomised crossover study in healthy adults. J Physiol. 2024 Sep;602(17):4157-4170. doi: 10.1113/JP286395. Epub 2024 Aug 4.
PubMed 39097829
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Acute Bout of Exercise on Serum Vitamin D Concentration
- ClinicalTrials.gov ID
- NCT05214027
- Acronym / sponsor ID
- EP 19/20 026
- Conditions
- Vitamin D, Acute Exercise
- Keywords
- Vitamin D, Acute Exercise, Adults, United Kingdom, Lipid Mobilisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 28 Jan 2022 (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.
Vitamin D deficiency is considered a public health priority in the UK, with approximately 30-40% of the UK population being deemed vitamin D deficient during winter months. Current government strategies to improve vitamin D status amongst the UK population involve dietary supplementation, however, it has been shown that excess adiposity reduces the impact of dietary supplementation with vitamin D. One potential explanation for this observation is that vitamin D becomes sequestered in adipose tissue. We hypothesise that exercise may facilitate the mobilisation of vitamin D from adipose tissue and thus increase circulating vitamin D (25OHD) concentrations. Little is currently known as to whether a single bout of exercise affects vitamin D status, with a handful of studies demonstrating contradictory findings. This research will examine the effect of an acute bout of exercise (treadmill-based at 60% VO2 Max for 60 minutes) on vitamin D status (serum 25(OH)D) in healthy community-dwelling adults.
Detailed description
This study is a random crossover design and will require 34 participants to visit the University of Bath on 6 separate occasions in total.
Individuals who express an interest in taking part will be invited to attend an initial screening meeting at the University so that the eligibility can be assessed for the study, and the all procedures explained verbally. If the participant is eligible and is happy to participate in the study, they will attend a second visit prior to two trials to undertake a treadmill-based maximal exercise test (VO2 Max), resting metabolic rate measure and several measures will be taken to assess body composition. Trials will involve a 60-minute exercise bout at 60% of the participant's maximum oxygen uptake or a 60-minute resting period (both followed by a further hour of rest). The order in which these trials occur will be randomised for each participant and the participant will not be told of this order prior to the trials.
During both trials, a cannula will be inserted into a vein in the arm prior to exercise and 10ml blood samples will be drawn at baseline (pre-exercise) and immediately after the exercise session and 1 hour post exercise from the antecubital vein. The participant will return to the university the day after each trial for a 10ml venous blood sample (24hr post-exercise) which will be taken via venepuncture. In the 24 hours following a trial, participants will be provided with standardised meals in order to ensure energy balance. Other controls which will be applied during the study period will include the provision of factor 50 sunscreen (if the participant is undertaking trials between March and October) to aid in mitigating against the cutaneous synthesis of vitamin D, and guidance on avoiding any strenuous activity 24 hours prior to trial days. Participants will also be provided with a physical activity monitor (MotionWatch8, CamNTech) to wear during trial days after leaving the lab.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Treadmill-Based Exercise (60% VO2 Max for 60 minutes), Other: Rest (60 minutes)This study follows a randomised crossover design. All participants will undergo a single 60-minute treadmill-based exercise intervention, and a resting period for equal duration in a randomised order. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy, community-dwelling adults (aged 25-65 years old)
Key inclusion criteria (3 listed)
- Healthy (see exclusion criteria)
- 25-65 years old
- Ability to travel to and from University of Bath campus
Key exclusion criteria (5 listed)
- Current or recent use (within the last three months) of weight loss drugs, medication that would interfere with study outcomes, sunbeds, or dietary vitamin D supplementation
- Change in weight of more than 5% in the last six months, or a significant change in lifestyle in the last two months
- Positive responses to the Physical Activity Readiness Questionnaire (PAR-Q)
- Presence of coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure, peripheral arterial disease, severe hypertension (blood pressure >180/110 mmHg)
- BMI <18kg/m2 or BMI >40kg/m2
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 |
|---|---|---|
| Treadmill-Based Exercise (60% VO2 Max for 60 minutes)Each participant will undergo a single 60-minute treadmill-based exercise intervention in a randomised order. Treadmill settings are generated based on settings which correspond to participants exercising at 60% VO2 max from their maximal exercise test on visit 2. To confirm that participants are exercising at 60% during the hour session, 1 minute samples of expired air are taken at 15 minute intervals and immediately analysed to check % VO2 max. Participants heart rate and RPE measures are also taken at 15 minute intervals throughout the exercise session and cross-checked against predicted values at 60% VO2 Max. | Other | Participants |
| Rest (60 minutes)Each participant will undergo a 60-minute rest period in a randomised order. | Other | Participants |
Primary outcome
Serum vitamin D concentration
Time frame: 24 hours- change from baseline to 24 hours post exercise
As assessed by serum 25(OH)D via LC-MS
3 secondary outcomes
Markers of lipid mobilisation
Time frame: 24 hours- change from baseline to 24 hours post exercise
Calcium
Time frame: 24 hours- change from baseline to 24 hours post exercise
Other vitamin D metabolites
Time frame: 24 hours- change from baseline to 24 hours post exercise
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 14 Nov 2022.
- Derived from this study: PubMed 39097829Davies SE, Perkin OJ, Betts JA, Gonzalez JT, Hewison M, Jenkinson C, Jones KS, Meadows SR, Parkington DA, Koulman A, Thompson D. The effect of an acute bout of exercise on circulating vitamin D metabolite concentrations: a randomised crossover study in healthy adults. J Physiol. 2024 Sep;602(17):4157-4170. doi: 10.1113/JP286395. Epub 2024 Aug 4.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D and Acute Exercise, run by University of Bath 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 5 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 14 Nov 2022. 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. 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 vitamin D concentration (time frame: 24 hours- change from baseline to 24 hours post exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05214027, which also lists 1 linked publication.
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 14 Nov 2022.