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| Name | Class |
|---|---|
| Dairy Council for Northern Ireland | OTHER |
| Agri-Food and Biosciences Institute | OTHER |
| Center for Nutrition and Health, RIVM (The Netherlands) | UNKNOWN |
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Vitamin D insufficiency has become a global concern, with low vitamin D status associated with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude, increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status, with lower levels noted in the winter months. Variations in vitamin D status have been known to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin D during the winter months, causing us to rely on dietary sources. The aim of this intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this intervention will affect subsequent dermal synthesis of vitamin D from UV exposure. Participants will be recruited from the local community. Blood samples will be collected from each participant at two timepoints (September/October and March/April). Pre- and post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences will be measured, in addition participants will undergo a dual energy x-ray absorptiometry (DXA) scan to assess body composition and bone mineral density. Information on general health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will be collected. Following the dietary intervention, a subset of participants will be invited to participate in a follow-up study, examining UV exposure during the summer months, when they will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2 additional blood samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | 500ml fortified milk (10µg vitamin D3) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks |
|
| Treatment 2 | Experimental | 500ml fortified milk (10µg vitamin D3) +1 supplement capsule (placebo) daily for 24 weeks |
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| Treatment 3 | Experimental | 500ml unfortified milk (placebo) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks |
|
| Treatment 4 | Placebo Comparator | 500ml unfortified milk (placebo) +1 supplement capsule (placebo) daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified milk (10µg vitamin D3) | Dietary Supplement |
| ||
| Unfortified milk (placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vitamin D status (25-hydroxyvitamin D serum concentration) | Blood analysis | Baseline + post-intervention (24weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition | Assessed by dual energy X-ray absorptiometry (DXA) | Baseline + post-intervention (24weeks) |
| Change in muscle strength | Assessed by grip strength |
| Measure | Description | Time Frame |
|---|---|---|
| UV exposure (follow-up) | Assessed by UV wrist monitors | 8 weeks post-intervention (32-40 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit | Coleraine | 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 Supplement |
|
| 10µg vitamin D3 supplement | Dietary Supplement |
|
| Placebo supplement | Dietary Supplement |
|
| Baseline + post-intervention (24weeks) |
| Change in inflammation status | Blood analysis | Baseline + post-intervention (24weeks) |
| Change in lipid profile | Blood analysis | Baseline + post-intervention (24weeks) |
| Change in glucose levels | Blood analysis | Baseline + post-intervention (24weeks) |
| Change in insulin concentrations | Blood analysis | Baseline + post-intervention (24weeks) |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |