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| Name | Class |
|---|---|
| Northern Ireland Executive | UNKNOWN |
| HSC Public Health Agency | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D oral spray solution | Active Comparator | An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray |
|
| Vitamin D capsules | Active Comparator | A capsule containing 3000IU (75micrograms) vitamin D3 per capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3000IU(75μg) vitamin D3 | Dietary Supplement |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela J Magee, PhD | University of Ulster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit (HISU), University of Ulster | Coleraine | Londonderry | BT52 1SA | United Kingdom |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire |
| At week 18 only |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |