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NCT Number: NCT02608164

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

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.

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Key information

Conditions

Vitamin D Concentration Vitamin D Status

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit (HISU), University of Ulster

Coleraine, Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3000IU(75μg) vitamin D3

Dietary Supplement

Other names: cholecalciferol

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • HSC Public Health Agency
  • Northern Ireland Executive

Registry information

Official study title

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

Acronym: SCD3

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2015
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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