A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status (SCD3)

May 24, 2016 updated by: Dr Pamela Magee, University of Ulster

A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status: a Randomised Crossover Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Londonderry
      • Coleraine, Londonderry, United Kingdom, BT52 1SA
        • Human Intervention Studies Unit (HISU), University of Ulster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D oral spray solution
An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray
Dietary supplement: 3000IU(75μg) vitamin D3
Other Names:
  • cholecalciferol
Active Comparator: Vitamin D capsules
A capsule containing 3000IU (75micrograms) vitamin D3 per capsule
Dietary supplement: 3000IU(75μg) vitamin D3
Other Names:
  • cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total 25-hydroxyvitamin D concentration
Time Frame: At baseline and weeks 4, 14 and 18
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers of vitamin D metabolism
Time Frame: At baseline and weeks 4, 14 and 18
Biomarkers of vitamin D metabolism, including parathyroid hormone and adjusted calcium will be quantified in collected serum samples by ELISA and using a clinical chemistry analyser
At baseline and weeks 4, 14 and 18
Dietary vitamin D intake
Time Frame: At week 18 only
Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire
At week 18 only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulster

Collaborators

Northern Ireland Executive
HSC Public Health Agency

Investigators

  • Principal Investigator: Pamela J Magee, PhD, University of Ulster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/15/0083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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