NCT02416895

Brief Summary

The purpose of this study is to examine the relationship between Vitamin D status and immunity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

March 25, 2015

Last Update Submit

April 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vitamin D measured by liquid chromatography tandem mass spectroscopy

    Circulating 25-hydroxy-vitamin D

    Up to 20 months

Secondary Outcomes (1)

  • Immune function measured by analytic biochemistry assay

    Up to 20 months

Study Arms (1)

Army recruits

Army recruits at the start of basic training will complete an in vivo immunity model

Other: In vivo immunity model

Interventions

A measure of in vivo immune function.

Army recruits

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adults who are starting basic training in the army.

You may qualify if:

  • Passed medical assessment by medical doctor
  • Passed audio test (this is part of medical assessment)
  • Met physical fitness requirements

You may not qualify if:

  • Medically deferred by medical doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infantry Training Centre

Catterick, North Yorkshire, DL9 3PS, United Kingdom

Location

Related Publications (2)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum collected at Week 1 (start of training) and Week 13 (end of training).

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Julie Greeves, PhD

    HQ Army Research and Training Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 15, 2015

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 5, 2017

Record last verified: 2017-03

Locations