Vitamin D Supplementation and Immunity/Physical Performance

NCT ID: NCT03132103

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-06

Study Completion Date

2017-08-31

Brief Summary

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The purpose of this study is to examine the effect of vitamin D supplementation on vitamin D status, immunity and physical performance.

Detailed Description

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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.

Conditions

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Vitamin D Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Solar simulated radiation (SSR)

Solar simulated radiation (SSR)

Group Type EXPERIMENTAL

Solar simulated radiation (SSR)

Intervention Type RADIATION

Placebo SSR

Placebo SSR

Group Type PLACEBO_COMPARATOR

Placebo SSR

Intervention Type RADIATION

Oral Vitamin D3

Oral Vitamin D3

Group Type EXPERIMENTAL

Oral Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo Oral Vitamin D3

Placebo Oral Vitamin D3

Group Type PLACEBO_COMPARATOR

Placebo Oral Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oral Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo Oral Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Solar simulated radiation (SSR)

Intervention Type RADIATION

Placebo SSR

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Passed medical assessment by medical doctor

Exclusion Criteria

* Medically deferred by medical doctor
* Regular sun bed use
* Holiday in a hot sunny climate in \<3 months
* Regular vitamin D supplementation
Minimum Eligible Age

17 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of East Anglia

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role collaborator

Bangor University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Infantry Training Centre

Catterick, North Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Prof Neil Walsh, PhD

Role: CONTACT

01248 ext. 383480

Dr Julie Greeves, PhD

Role: CONTACT

01264 ext. 886827

Facility Contacts

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Neil P Walsh, PhD

Role: primary

01248 ext. 3480

Julie P Greeves, PhD

Role: backup

94344 ext. 8193

References

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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.

Reference Type DERIVED
PMID: 32390123 (View on PubMed)

Other Identifiers

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692/Gen/10

Identifier Type: -

Identifier Source: org_study_id

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