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Vitamin D Supplementation and Immunity/Physical Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03132103
Recruitment Status : Unknown
Verified April 2017 by Bangor University.
Recruitment status was:  Recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
University of East Anglia
University of Manchester
Information provided by (Responsible Party):
Bangor University

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

Condition or disease Intervention/treatment Phase
Vitamin D Status Dietary Supplement: Oral Vitamin D3 Dietary Supplement: Placebo Oral Vitamin D3 Radiation: Solar simulated radiation (SSR) Radiation: Placebo SSR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin D Supplementation on Vitamin D Status, Immunity and Physical Performance
Actual Study Start Date : January 6, 2016
Estimated Primary Completion Date : April 28, 2017
Estimated Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Vitamin D status [ Time Frame: Up to 20 months ]
    Circulating 25-hydroxy-vitamin D, 1,25-d OH(OH)D


Secondary Outcome Measures :
  1. Physical performance 1 [ Time Frame: Up to 20 months ]
    Vertical Jump height (cm) and peak power output (watts)

  2. Physical performance 2 [ Time Frame: Up to 20 months ]
    Maximal dynamic lift strength (kg)

  3. Physical performance 3 [ Time Frame: Up to 20 months ]
    Multi-stage fitness test predicted VO2max (mL/kg/min)

  4. Hepatitis B antibody [ Time Frame: Up to 20 months ]
    Antibody produced in response to the presence of Hepatitis B antigen (e.g. Hepatitis B vaccine)

  5. Mucosal immunity [ Time Frame: Up to 20 months ]
    Secretory Immunoglobulin A levels



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132103


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

Locations
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United Kingdom
Infantry Training Centre Recruiting
Catterick, North Yorkshire, United Kingdom, DL9 3PS
Contact: Neil P Walsh, PhD    01248 ext 3480    n.walsh@bangor.ac.uk   
Contact: Julie P Greeves, PhD    94344 ext 8193    ARTD-OccMed-SSO@mod.uk   
Principal Investigator: Julie P Greeves, PhD         
Sponsors and Collaborators
Bangor University
University of East Anglia
University of Manchester
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT03132103    
Other Study ID Numbers: 692/Gen/10
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bangor University:
Vitamin D deficiency
Simulated sunlight radiation
Oral vitamin D3
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents