NCT03132103

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

March 30, 2017

Last Update Submit

April 24, 2017

Conditions

Keywords

Vitamin D deficiencySimulated sunlight radiationOral vitamin D3

Outcome Measures

Primary Outcomes (1)

  • Vitamin D status

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

    Up to 20 months

Secondary Outcomes (5)

  • Physical performance 1

    Up to 20 months

  • Physical performance 2

    Up to 20 months

  • Physical performance 3

    Up to 20 months

  • Hepatitis B antibody

    Up to 20 months

  • Mucosal immunity

    Up to 20 months

Study Arms (4)

Solar simulated radiation (SSR)

EXPERIMENTAL

Solar simulated radiation (SSR)

Radiation: Solar simulated radiation (SSR)

Placebo SSR

PLACEBO COMPARATOR

Placebo SSR

Radiation: Placebo SSR

Oral Vitamin D3

EXPERIMENTAL

Oral Vitamin D3

Dietary Supplement: Oral Vitamin D3

Placebo Oral Vitamin D3

PLACEBO COMPARATOR

Placebo Oral Vitamin D3

Dietary Supplement: Placebo Oral Vitamin D3

Interventions

Oral Vitamin D3DIETARY_SUPPLEMENT
Oral Vitamin D3
Placebo Oral Vitamin D3DIETARY_SUPPLEMENT
Placebo Oral Vitamin D3
Solar simulated radiation (SSR)
Placebo SSRRADIATION
Placebo SSR

Eligibility Criteria

Age17 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Passed medical assessment by medical doctor

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infantry Training Centre

Catterick, North Yorkshire, DL9 3PS, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Central Study Contacts

Prof Neil Walsh, PhD

CONTACT

Dr Julie Greeves, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 27, 2017

Study Start

January 6, 2016

Primary Completion

April 28, 2017

Study Completion

August 31, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations