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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vitamin D Concentration, Vitamin D Status

Intervention / Treatment
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* Dietary Supplement: 3000IU(75μg) vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D oral spray solution<br>An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray | Dietary Supplement: 3000IU(75μg) vitamin D3<br> <br> * Other names: cholecalciferol;|
| Active Comparator: Vitamin D capsules<br>A capsule containing 3000IU (75micrograms) vitamin D3 per capsule | Dietary Supplement: 3000IU(75μg) vitamin D3<br> <br> * Other names: cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Dietary vitamin D intake | Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire | At week 18 only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy adults