Vitamin D DeficiencyNCT02416895
Vitamin D Status and Immune Function
An observational study of Vitamin D Deficiency, run by Bangor University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to examine the relationship between Vitamin D status and immunity. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- In vivo immunity model
- How many people
- 264 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Dec 2015
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults who are starting basic training in the army.
Who may be able to join
- Passed medical assessment by medical doctor
- Passed audio test (this is part of medical assessment)
- Met physical fitness requirements
Who cannot join
- Medically deferred by medical doctor
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Infantry Training Centre
Catterick, North Yorkshire, DL9 3PS
About this study
Official title: Vitamin D Status and in Vivo Immune Function
The purpose of this study is to examine the relationship between Vitamin D status and immunity.
Read the detailed description
Vitamin D is mainly obtained from the sun and follows a seasonal pattern, with Vitamin D levels peaking in summer and reaching a trough during winter. Vitamin D deficiency is associated with impaired immunity. However, knowledge of Vitamin D deficiency with in vivo immunity is limited. This observational study aims to investigate the relationship between Vitamin D status and the in vivo immunity.
- Conditions
- Vitamin D Deficiency
- Being tested
- In vivo immunity model
- 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.
In vivo immunity modelOther
A measure of in vivo immune function.
| Study group | Role | What they receive |
|---|---|---|
| Army recruits | Army recruits at the start of basic training will complete an in vivo immunity model Receives: Other: In vivo immunity model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D measured by liquid chromatography tandem mass spectroscopy
Circulating 25-hydroxy-vitamin D
Measured: Up to 20 months
Secondary outcomes (1)
Immune function measured by analytic biochemistry assay
In vivo immune measure
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 posted15 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Julie Greeves, PhD, Principal investigator, HQ Army Research and Training Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416895
- Sponsor's protocol ID
- 165/Gen/10
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2015
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 32390123Tang JCY, Jackson S, Walsh NP, Greeves J, Fraser WD; Bioanalytical Facility team. The dynamic relationships between the active and catabolic vitamin D metabolites, their ratios, and associations with PTH. Sci Rep. 2019 May 6;9(1):6974. doi: 10.1038/s41598-019-43462-6.
PubMed 31061425
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status and in Vivo Immune Function
- ClinicalTrials.gov ID
- NCT02416895
- Acronym / sponsor ID
- 165/Gen/10
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Apr 2015 (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 purpose of this study is to examine the relationship between Vitamin D status and immunity.
Detailed description
Vitamin D is mainly obtained from the sun and follows a seasonal pattern, with Vitamin D levels peaking in summer and reaching a trough during winter. Vitamin D deficiency is associated with impaired immunity. However, knowledge of Vitamin D deficiency with in vivo immunity is limited. This observational study aims to investigate the relationship between Vitamin D status and the in vivo immunity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Army recruits | – | Other: In vivo immunity modelArmy recruits at the start of basic training will complete an in vivo immunity model |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults who are starting basic training in the army.
Key inclusion criteria (3 listed)
- Passed medical assessment by medical doctor
- Passed audio test (this is part of medical assessment)
- Met physical fitness requirements
Key exclusion criteria (1 listed)
- Medically deferred by medical doctor
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 |
|---|---|---|
| In vivo immunity modelA measure of in vivo immune function. | Other | Army recruits |
Primary outcome
Vitamin D measured by liquid chromatography tandem mass spectroscopy
Time frame: Up to 20 months
Circulating 25-hydroxy-vitamin D
1 secondary outcome
Immune function measured by analytic biochemistry assay
Time frame: Up to 20 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 5 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.
- Derived from this study: PubMed 31061425Tang JCY, Jackson S, Walsh NP, Greeves J, Fraser WD; Bioanalytical Facility team. The dynamic relationships between the active and catabolic vitamin D metabolites, their ratios, and associations with PTH. Sci Rep. 2019 May 6;9(1):6974. doi: 10.1038/s41598-019-43462-6.
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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.
Julie Greeves, PhD principal investigator
HQ Army Research and Training Division
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 Deficiency, 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 3 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 5 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. 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?
Vitamin D measured by liquid chromatography tandem mass spectroscopy (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 NCT02416895, which also lists 2 linked publications.
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 5 Apr 2017; AzTrials last refreshed its copy on 4 Nov 2026.