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The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week supplementation study during winter months.
The UK (McCance & Widdowson) food composition tables suggests that 25-hydroxyvitamin D (which is present in some foods, albeit at very low concentrations, but which is also commercially available) may possess up to 5-times the activity of native vitamin D3 in food. Thus, in theory, each micogram of 25-hydroxyvitamin D consumed in the diet could boost vitamin D status up to five times most effectively compared to each microgram of native vitamin D in food. It is worth noting, however, that estimates of potency range from 2 to 5, depending on approach used, and that the real potency needs to be confirmed in a human study. This study aims to examine the biological activity of 25-hydroxyvitamin D (i.e., its potency relative to vitamin D3) as well as its effect on selected functional markers in a randomised, double-blind, human intervention trial in older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 (20 microgram/day) | Active Comparator |
| |
| 25-hydroxyvitamin D (7 microgram/day) | Active Comparator |
| |
| 25-hydroxyvitamin D3 (20 micogram/day) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 | Dietary Supplement | 20 micrograms per day for 10 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| serum 25-hydroxyvitamin D concentration | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| serum parathyroid hormone | 10 weeks | |
| blood pressure | 10 weeks | |
| biochemical markers of bone turnover |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin D Cashman, PhD | University College Cork | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Cork | Cork | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22552038 | Derived | Cashman KD, Seamans KM, Lucey AJ, Stocklin E, Weber P, Kiely M, Hill TR. Relative effectiveness of oral 25-hydroxyvitamin D3 and vitamin D3 in raising wintertime serum 25-hydroxyvitamin D in older adults. Am J Clin Nutr. 2012 Jun;95(6):1350-6. doi: 10.3945/ajcn.111.031427. Epub 2012 May 2. |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D002112 | Calcifediol |
| C104450 | 25-hydroxyvitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 25-hydroxyvitamin D3 |
| Dietary Supplement |
7 microgram/day for 10 weeks |
|
| 25-hydroxyvitamin D (20 microgram/day) | Dietary Supplement | 20 microgramday for 10 weeks |
|
| Placebo | Dietary Supplement | 0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks |
|
| 10 weeks |
| serum calcium adjusted for albumin | 10 weeks |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D006887 | Hydroxycholecalciferols |