Vitamin D Status and Immune Function | NCT02416895

Studies
Vitamin D Status and Immune Function

NCT02416895

Sponsor

Bangor University

Status

Completed

Last Update Posted

Apr 5, 2017Actual

Enrollment

264Actual

Phase

Not provided

Conditions

Vitamin D Deficiency

Interventions

In vivo immunity model

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Mar 25, 2015

First Submission Date that Met QC Criteria

Apr 9, 2015

First Posted Date

Apr 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2017

Last Update Posted Date

Apr 5, 2017Actual

Name	Class
University of East Anglia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

264Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Army recruits		Army recruits at the start of basic training will complete an in vivo immunity model	Other: In vivo immunity model

Interventions

Name	Type	Description	Arm Group Labels	Other Names
In vivo immunity model	Other	A measure of in vivo immune function.	Army recruits

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vitamin D measured by liquid chromatography tandem mass spectroscopy	Circulating 25-hydroxy-vitamin D	Up to 20 months

Secondary Outcomes

Measure	Description	Time Frame
Immune function measured by analytic biochemistry assay	In vivo immune measure	Up to 20 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Young adults who are starting basic training in the army.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie Greeves, PhD	HQ Army Research and Training Division	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Infantry Training Centre		Catterick	North Yorkshire	DL9 3PS	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32390123	Derived	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.
31061425

Type	Date	Date Unknown
Release	Feb 5, 2025
Reset	Feb 26, 2025

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders