Vitamin D Supplementation and Immunity/Physical Performance

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

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

Study Overview

• Status: Unknown
• Conditions: Vitamin D Status
• Intervention / Treatment: Radiation: Solar simulated radiation (SSR); Radiation: Placebo SSR; Dietary supplement: Oral Vitamin D3; Dietary supplement: Placebo Oral Vitamin D3

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof Neil Walsh, PhD; Phone Number: 383480 01248; Email: n.walsh@bangor.ac.uk
• Study Contact Backup: Name: Dr Julie Greeves, PhD; Phone Number: 886827 01264; Email: ArmyMed-SHA-APRC-ResDir@mod.uk

Study Locations

• United Kingdom
  • North Yorkshire
    • Catterick, North Yorkshire, United Kingdom, DL9 3PS
      • Recruiting
      • Infantry Training Centre
      • Contact: Neil P Walsh, PhD; Phone Number: 3480 01248; Email: n.walsh@bangor.ac.uk
      • Contact: Julie P Greeves, PhD; Phone Number: 8193 94344; Email: ARTD-OccMed-SSO@mod.uk
      • Principal Investigator: Julie P Greeves, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solar simulated radiation (SSR)	Radiation: Solar simulated radiation (SSR)
Placebo Comparator: Placebo SSR	Radiation: Placebo SSR
Experimental: Oral Vitamin D3	Dietary supplement: Oral Vitamin D3
Placebo Comparator: Placebo Oral Vitamin D3	Dietary supplement: Placebo Oral Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D status	Circulating 25-hydroxy-vitamin D, 1,25-d OH(OH)D	Up to 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical performance 1	Vertical Jump height (cm) and peak power output (watts)	Up to 20 months
Physical performance 2	Maximal dynamic lift strength (kg)	Up to 20 months
Physical performance 3	Multi-stage fitness test predicted VO2max (mL/kg/min)	Up to 20 months
Hepatitis B antibody	Antibody produced in response to the presence of Hepatitis B antigen (e.g. Hepatitis B vaccine)	Up to 20 months
Mucosal immunity	Secretory Immunoglobulin A levels	Up to 20 months

Collaborators and Investigators

• Sponsor: Bangor University
• Collaborators: University of East Anglia; University of Manchester

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2016
• Primary Completion (Anticipated): April 28, 2017
• Study Completion (Anticipated): August 31, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin D deficiency; Simulated sunlight radiation; Oral vitamin D3
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 692/Gen/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No