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NCT03132103 Clinical Trial

Vitamin D Supplementation and Immunity/Physical Performance

Vitamin D Status Clinical Trial

Official title:
The Effect of Vitamin D Supplementation on Vitamin D Status, Immunity and Physical Performance

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03132103
Other study ID # 692/Gen/10
Secondary ID
Status Recruiting
Phase N/A
First received March 30, 2017
Last updated April 24, 2017
Start date January 6, 2016
Est. completion date August 31, 2017

Study information
Verified date April 2017
Source Bangor University
Contact Prof Neil Walsh, PhD
Phone 01248
Email n.walsh@bangor.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 260
Est. completion date August 31, 2017
Est. primary completion date April 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 17 Years to 35 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oral Vitamin D3

• Placebo Oral Vitamin D3

Radiation:
• Solar simulated radiation (SSR)

• Placebo SSR

Locations
Country Name City State
United Kingdom Infantry Training Centre Catterick North Yorkshire

Sponsors (3)
Lead Sponsor Collaborator
Bangor University University of East Anglia, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitamin D status Circulating 25-hydroxy-vitamin D, 1,25-d OH(OH)D Up to 20 months
Secondary Physical performance 1 Vertical Jump height (cm) and peak power output (watts) Up to 20 months
Secondary Physical performance 2 Maximal dynamic lift strength (kg) Up to 20 months
Secondary Physical performance 3 Multi-stage fitness test predicted VO2max (mL/kg/min) Up to 20 months
Secondary Hepatitis B antibody Antibody produced in response to the presence of Hepatitis B antigen (e.g. Hepatitis B vaccine) Up to 20 months
Secondary Mucosal immunity Secretory Immunoglobulin A levels Up to 20 months
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