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

Vitamin D Status Clinical Trial

— SCD3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608164
• Other study ID #: REC/15/0083
• Status: Completed
• Phase: N/A
• First received: November 16, 2015
• Last updated: May 24, 2016
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Concentration
• Vitamin D Status

Intervention

Dietary Supplement:
• 3000IU(75µg) vitamin D3

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit (HISU), University of Ulster	Coleraine	Londonderry

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulster	HSC Public Health Agency, Northern Ireland Executive

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Biomarkers of vitamin D metabolism	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	No
Secondary	Dietary vitamin D intake	Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire	At week 18 only	No