A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status

NCT ID: NCT02608164

Last Updated: 2016-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vitamin D Concentration Vitamin D Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vitamin D oral spray solution

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

Group Type ACTIVE_COMPARATOR

3000IU(75μg) vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D capsules

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

Group Type ACTIVE_COMPARATOR

3000IU(75μg) vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Interventions

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3000IU(75μg) vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy
* Over the age of 18

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northern Ireland Executive

UNKNOWN

Sponsor Role collaborator

HSC Public Health Agency

UNKNOWN

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Dr Pamela Magee

Dr Pamela Magee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela J Magee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ulster

Locations

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Human Intervention Studies Unit (HISU), University of Ulster

Coleraine, Londonderry, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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REC/15/0083

Identifier Type: -

Identifier Source: org_study_id

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