NCT02608164

Brief Summary

The aim of the study is to compare the effectiveness of a vitamin D3 oral spray solution with capsules at raising vitamin D status over winter. This randomised crossover trial will aim to recruit a total of 22 healthy participants for a total of two 4-week interventions separated by a 10-week washout.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

November 16, 2015

Last Update Submit

May 24, 2016

Conditions

Vitamin D ConcentrationVitamin D Status

Keywords

Healthy adults

Outcome Measures

Primary Outcomes (1)

  • Total 25-hydroxyvitamin D concentration

    Total 25-hydroxyvitamin D concentration will be determined using liquid chromatography-tandem mass spectrometry in collected serum samples

    At baseline and weeks 4, 14 and 18

Secondary Outcomes (2)

  • Biomarkers of vitamin D metabolism

    At baseline and weeks 4, 14 and 18

  • Dietary vitamin D intake

    At week 18 only

Study Arms (2)

Vitamin D oral spray solution

ACTIVE COMPARATOR

An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray

Dietary Supplement: 3000IU(75μg) vitamin D3

Vitamin D capsules

ACTIVE COMPARATOR

A capsule containing 3000IU (75micrograms) vitamin D3 per capsule

Dietary Supplement: 3000IU(75μg) vitamin D3

Interventions

3000IU(75μg) vitamin D3DIETARY_SUPPLEMENT
Also known as: cholecalciferol
Vitamin D capsulesVitamin D oral spray solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apparently healthy
  • Over the age of 18

You may not qualify if:

  • Those that intend to consume a supplement containing vitamin D at any point during the study
  • Those under the age of 18.
  • Individuals that are on prescribed medication that is known to affect vitamin D metabolism
  • Those following a vegan diet
  • Sun-bed users
  • Participants that are planning a sun holiday during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Intervention Studies Unit (HISU), University of Ulster

Coleraine, Londonderry, BT52 1SA, United Kingdom

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Pamela J Magee, PhD

    University of Ulster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Pamela Magee

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

GB(1)