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

University of Ulster22 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Vitamin D Concentration Vitamin D Status

Interventions

3000IU(75μg) vitamin D3DIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Human Intervention Studies Unit (HISU), University of Ulster

Coleraine, Londonderry, United Kingdom

Outcomes

Primary Outcomes

Total 25-hydroxyvitamin D concentration

Total 25-hydroxyvitamin D concentration will be determined using liquid chromatography-tandem mass spectrometry in collected serum samples

Time frame: At baseline and weeks 4, 14 and 18

Secondary Outcomes

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

Time frame: At baseline and weeks 4, 14 and 18

Dietary vitamin D intake

Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire

Time frame: At week 18 only

Data from ClinicalTrials.gov

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