Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults
| Registry | NCT01398202 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 56 (Actual) |
| Sponsor | University College Cork (Other) |
| Conditions | Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D |
| Interventions | vitamin D3, 25-hydroxyvitamin D3, 25-hydroxyvitamin D (20 microgram/day), Placebo (Dietary supplement) |
| Dates | start 2011-01-01, primary completion 2011-07-01, completion 2011-09-01, first posted 2011-07-20, last updated 2015-12-02 |
| Locations | 1 site in Ireland |
Related Papers Related Patents Related Grants Related Experts
All trials for Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D All trials of vitamin D3 All trials of 25-hydroxyvitamin D3
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vitamin D3 (20 microgram/day) | Active comparator | Dietary Supplement: vitamin D3 | |
| 25-hydroxyvitamin D (7 microgram/day) | Active comparator | Dietary Supplement: 25-hydroxyvitamin D3 | |
| 25-hydroxyvitamin D3 (20 micogram/day) | Active comparator | Dietary Supplement: 25-hydroxyvitamin D (20 microgram/day) | |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Sex: All, ages: 45 Years to any, accepts healthy volunteers
Inclusion Criteria: * Subjects will be eligible if they are 45+ years of age * Body Mass Index (BMI) 19-30 Exclusion Criteria: * have hypercalcaemia * chronic illness * renal or liver disorders * taking medications that might interact with vitamin D or metabolite * drank more than > 21 standards (male)/ 14 standards (female) of alcohol per week * planning to change smoking habits
| Facility | City | Country | Status |
|---|---|---|---|
| University College Cork | Cork | Ireland |