Vitamin D StatusNCT03132103
Vitamin D Supplementation and Immunity/Physical Performance
A study testing Oral Vitamin D3 and Solar simulated radiation (SSR) in people with Vitamin D Status, run by Bangor University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to examine the effect of vitamin D supplementation on vitamin D status, immunity and physical performance. Read more about this study
- Who is it for?
- Ages 17 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status
- What is being tested?
- Oral Vitamin D3 and Solar simulated radiation (SSR)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2016to 31 Aug 2017
- Phase
- Interventional
- 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 17 to 35 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Passed medical assessment by medical doctor
Who cannot join
- Medically deferred by medical doctor
- Regular sun bed use
- Holiday in a hot sunny climate in <3 months
- Regular vitamin D supplementation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Infantry Training Centre
Catterick, North Yorkshire, DL9 3PS
Neil P Walsh, PhD, 01248 ext. 3480, n.walsh@bangor.ac.uk
Julie P Greeves, PhD, 94344 ext. 8193, ARTD-OccMed-SSO@mod.uk
About this study
Official title: The Effect of Vitamin D Supplementation on Vitamin D Status, Immunity and Physical Performance
The purpose of this study is to examine the effect of vitamin D supplementation on vitamin D status, immunity and physical performance.
Read the detailed description
Vitamin D plays a key role in bone mineralisation and has been linked to immune defence maintenance and muscle function. Vitamin D is primarily obtained from endogenous synthesis in response to skin sunlight exposure and follows a seasonal pattern; whereby, vitamin D levels peak at the end of the summer and fall to a trough during winter. If winter vitamin D levels can be increased to match those found in summer using supplementation, it is proposed sufficient vitamin D levels will improve physical performance and reduce susceptibility to illness in military recruits.
- Conditions
- Vitamin D Status
- Being tested
- Oral Vitamin D3, Placebo Oral Vitamin D3, Solar simulated radiation (SSR), Placebo SSR
- Keywords
- Vitamin D deficiency, Simulated sunlight radiation, Oral vitamin D3
- 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.
Oral Vitamin D3Dietary supplement
Placebo Oral Vitamin D3Dietary supplement
Solar simulated radiation (SSR)Radiation
Placebo SSRRadiation
| Study group | Role | What they receive |
|---|---|---|
| Solar simulated radiation (SSR) | Experimental | Solar simulated radiation (SSR) Receives: Radiation: Solar simulated radiation (SSR) |
| Placebo SSR | Placebo comparator | Placebo SSR Receives: Radiation: Placebo SSR |
| Oral Vitamin D3 | Experimental | Oral Vitamin D3 Receives: Dietary Supplement: Oral Vitamin D3 |
| Placebo Oral Vitamin D3 | Placebo comparator | Placebo Oral Vitamin D3 Receives: Dietary Supplement: Placebo Oral Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status
Circulating 25-hydroxy-vitamin D, 1,25-d OH(OH)D
Measured: Up to 20 months
Secondary outcomes (5)
Physical performance 1
Vertical Jump height (cm) and peak power output (watts)
Measured: Up to 20 months
Physical performance 2
Maximal dynamic lift strength (kg)
Measured: Up to 20 months
Physical performance 3
Multi-stage fitness test predicted VO2max (mL/kg/min)
Measured: Up to 20 months
Hepatitis B antibody
Antibody produced in response to the presence of Hepatitis B antigen (e.g. Hepatitis B vaccine)
Measured: Up to 20 months
Mucosal immunity
Secretory Immunoglobulin A levels
Measured: Up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start6 Jan 2016
- Primary completion28 Apr 2017 (estimated)
- Study completion31 Aug 2017 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia, University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132103
- Sponsor's protocol ID
- 692/Gen/10
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kashi DS, Oliver SJ, Wentz LM, Roberts R, Carswell AT, Tang JCY, Jackson S, Izard RM, Allan D, Rhodes LE, Fraser WD, Greeves JP, Walsh NP. Vitamin D and the hepatitis B vaccine response: a prospective cohort study and a randomized, placebo-controlled oral vitamin D3 and simulated sunlight supplementation trial in healthy adults. Eur J Nutr. 2021 Feb;60(1):475-491. doi: 10.1007/s00394-020-02261-w. Epub 2020 May 10.
PubMed 32390123
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on Vitamin D Status, Immunity and Physical Performance
- ClinicalTrials.gov ID
- NCT03132103
- Acronym / sponsor ID
- 692/Gen/10
- Conditions
- Vitamin D Status
- Keywords
- Vitamin D deficiency, Simulated sunlight radiation, Oral vitamin D3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Collaborators
- University of East Anglia, University of Manchester
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 28 Apr 2017 (estimated)
- Study completion
- 31 Aug 2017 (estimated)
- First posted
- 27 Apr 2017 (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.
The purpose of this study is to examine the effect of vitamin D supplementation on vitamin D status, immunity and physical performance.
Detailed description
Vitamin D plays a key role in bone mineralisation and has been linked to immune defence maintenance and muscle function. Vitamin D is primarily obtained from endogenous synthesis in response to skin sunlight exposure and follows a seasonal pattern; whereby, vitamin D levels peak at the end of the summer and fall to a trough during winter. If winter vitamin D levels can be increased to match those found in summer using supplementation, it is proposed sufficient vitamin D levels will improve physical performance and reduce susceptibility to illness in military recruits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Solar simulated radiation (SSR) | Experimental | Radiation: Solar simulated radiation (SSR)Solar simulated radiation (SSR) |
| Placebo SSR | Placebo comparator | Radiation: Placebo SSRPlacebo SSR |
| Oral Vitamin D3 | Experimental | Dietary Supplement: Oral Vitamin D3Oral Vitamin D3 |
| Placebo Oral Vitamin D3 | Placebo comparator | Dietary Supplement: Placebo Oral Vitamin D3Placebo Oral Vitamin D3 |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Passed medical assessment by medical doctor
Key exclusion criteria (4 listed)
- Medically deferred by medical doctor
- Regular sun bed use
- Holiday in a hot sunny climate in <3 months
- Regular vitamin D supplementation
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 |
|---|---|---|
| Oral Vitamin D3 | Dietary supplement | Oral Vitamin D3 |
| Placebo Oral Vitamin D3 | Dietary supplement | Placebo Oral Vitamin D3 |
| Solar simulated radiation (SSR) | Radiation | Solar simulated radiation (SSR) |
| Placebo SSR | Radiation | Placebo SSR |
Primary outcome
Vitamin D status
Time frame: Up to 20 months
Circulating 25-hydroxy-vitamin D, 1,25-d OH(OH)D
5 secondary outcomes
Physical performance 1
Time frame: Up to 20 months
Physical performance 2
Time frame: Up to 20 months
Physical performance 3
Time frame: Up to 20 months
Hepatitis B antibody
Time frame: Up to 20 months
Mucosal immunity
Time frame: Up to 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Derived from this study: PubMed 32390123Kashi DS, Oliver SJ, Wentz LM, Roberts R, Carswell AT, Tang JCY, Jackson S, Izard RM, Allan D, Rhodes LE, Fraser WD, Greeves JP, Walsh NP. Vitamin D and the hepatitis B vaccine response: a prospective cohort study and a randomized, placebo-controlled oral vitamin D3 and simulated sunlight supplementation trial in healthy adults. Eur J Nutr. 2021 Feb;60(1):475-491. doi: 10.1007/s00394-020-02261-w. Epub 2020 May 10.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Vitamin D3 and Solar simulated radiation (SSR) in people with Vitamin D Status, run by Bangor University 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Apr 2017. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof Neil Walsh, PhD (01248 ext. 383480, n.walsh@bangor.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D status (time frame: Up to 20 months). 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 NCT03132103, 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 27 Apr 2017.