Vitamin D Concentration, Vitamin D Status
Conditions
Keywords
Healthy adults
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.
Interventions
DIETARY_SUPPLEMENT3000IU(75μg) vitamin D3
Sponsors
Northern Ireland Executive
HSC Public Health Agency
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed