- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02416895
Vitamin D Status and Immune Function
April 4, 2017 updated by: Bangor University
Vitamin D Status and in Vivo Immune Function
The purpose of this study is to examine the relationship between Vitamin D status and immunity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
264
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Yorkshire
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Catterick, North Yorkshire, United Kingdom, DL9 3PS
- Infantry Training Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Young adults who are starting basic training in the army.
Description
Inclusion Criteria:
- Passed medical assessment by medical doctor
- Passed audio test (this is part of medical assessment)
- Met physical fitness requirements
Exclusion Criteria:
• Medically deferred by medical doctor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Army recruits
Army recruits at the start of basic training will complete an in vivo immunity model
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A measure of in vivo immune function.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D measured by liquid chromatography tandem mass spectroscopy
Time Frame: Up to 20 months
|
Circulating 25-hydroxy-vitamin D
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Up to 20 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune function measured by analytic biochemistry assay
Time Frame: Up to 20 months
|
In vivo immune measure
|
Up to 20 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Greeves, PhD, HQ Army Research and Training Division
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Tang 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
March 25, 2015
First Submitted That Met QC Criteria
April 9, 2015
First Posted (Estimate)
April 15, 2015
Study Record Updates
Last Update Posted (Actual)
April 5, 2017
Last Update Submitted That Met QC Criteria
April 4, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 165/Gen/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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