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

Not Applicable

Completed

• Conditions: Vitamin D Concentration; Vitamin D Status
• Interventions: Dietary Supplement: 3000IU(75μg) vitamin D3

• Registration Number: NCT02608164
• Lead Sponsor: University of Ulster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Primary Completion: 2016-03
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin D oral spray solution	3000IU(75μg) vitamin D3	An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray
Vitamin D capsules	3000IU(75μg) vitamin D3	A capsule containing 3000IU (75micrograms) vitamin D3 per capsule

Primary Outcome Measures

Name	Time	Method
Total 25-hydroxyvitamin D concentration	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 Outcome Measures

Name	Time	Method
Biomarkers of vitamin D metabolism	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
Dietary vitamin D intake	At week 18 only	Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire

Trial Locations

Locations (1)

Human Intervention Studies Unit (HISU), University of Ulster; 🇬🇧 Coleraine, Londonderry, United Kingdom