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Status unknownNCT03132103Updated Apr 27, 2017

Vitamin D Supplementation and Immunity/Physical Performance

An interventional study of Oral Vitamin D3 and Placebo Oral Vitamin D3 in Vitamin D Status, sponsored by Bangor University. Status unknown at 1 site in United Kingdom. Open to male participants aged 17 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-27.

Sponsored by Bangor University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2016, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
17 Years to 35 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Vitamin D Status

Keywords

  • Vitamin D deficiency
  • Simulated sunlight radiation
  • Oral vitamin D3
03

In context

Lead sponsor

Bangor University is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Passed medical assessment by medical doctor

Exclusion criteria

Exclusion Criteria:

  • Medically deferred by medical doctor
  • Regular sun bed use
  • Holiday in a hot sunny climate in \<3 months
  • Regular vitamin D supplementation
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    Solar simulated radiation (SSR)

    Solar simulated radiation (SSR)

    Radiation: Solar simulated radiation (SSR)

  • Placebo comparator
    Placebo SSR

    Placebo SSR

    Radiation: Placebo SSR

  • Experimental
    Oral Vitamin D3

    Oral Vitamin D3

    Dietary Supplement: Oral Vitamin D3

  • Placebo comparator
    Placebo Oral Vitamin D3

    Placebo Oral Vitamin D3

    Dietary Supplement: Placebo Oral Vitamin D3

Interventions

  • Dietary supplementOral Vitamin D3
  • Dietary supplementPlacebo Oral Vitamin D3
  • RadiationSolar simulated radiation (SSR)
  • RadiationPlacebo SSR
06

What researchers measure

Primary outcomes

  1. Vitamin D status

    Circulating 25-hydroxy-vitamin D, 1,25-d OH(OH)D

    Time frame: Up to 20 months

Secondary outcomes

  1. Physical performance 1

    Vertical Jump height (cm) and peak power output (watts)

    Time frame: Up to 20 months

  2. Physical performance 2

    Maximal dynamic lift strength (kg)

    Time frame: Up to 20 months

  3. Physical performance 3

    Multi-stage fitness test predicted VO2max (mL/kg/min)

    Time frame: Up to 20 months

  4. Hepatitis B antibody

    Antibody produced in response to the presence of Hepatitis B antigen (e.g. Hepatitis B vaccine)

    Time frame: Up to 20 months

  5. Mucosal immunity

    Secretory Immunoglobulin A levels

    Time frame: Up to 20 months

07

Study locations

1 of 1 sites recruiting
  • Infantry Training Centre
    Catterick, North Yorkshire DL9 3PS, United Kingdom
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03132103
Lead sponsor
Bangor University
Collaborators
University of East Anglia, University of Manchester
Responsible party
Sponsor
First posted
Apr 27, 2017
Start date
Jan 6, 2016
Primary completion
Apr 28, 2017 (estimated)
Completion
Aug 31, 2017 (estimated)
Last update
Apr 27, 2017

Study contacts

Prof Neil Walsh, PhD
Contact
n.walsh@bangor.ac.uk
01248 ext. 383480
Dr Julie Greeves, PhD
Contact
ArmyMed-SHA-APRC-ResDir@mod.uk
01264 ext. 886827

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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