Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the dose of Hy.D Calcifediol 25 SD/S (a metabolite of vitamin D3) which will achieve the range of mean serum 25(OH)D between 75-100nmol/L in physically frail elderly people after 24 weeks of daily supplementation with different doses of Hy.D Calcifediol 25 SD/S compared to vitamin D3.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 µg/day Hy.D Calcifediol | Experimental |
| |
| 10 µg/day Hy.D Calcifediol | Experimental |
| |
| 15 µg/day Hy.D Calcifediol | Experimental |
| |
| 20 µg/day vitamin D3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 µg/day Hy.D Calcifediol | Dietary Supplement | 5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baseline | Outcome measurement: Mean serum 25(OH)D levels at baseline before supplementation of three doses of Hy.D and 1 dose of vitamin D3. | Baseline (day 0) |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 4 weeks | Outcome measurement: Mean serum 25(OH)D levels after 4 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. | 4 weeks after initial compound intake |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 8 weeks | Outcome measurement: Mean serum 25(OH)D levels after 8 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. | 8 weeks after initial compound intake |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 12 weeks | Outcome measurement: Mean serum 25(OH)D levels after 12 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. | 12 weeks after initial compound intake |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 16 weeks | Outcome measurement: Mean serum 25(OH)D levels after 16 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. | 16 weeks after initial compound intake |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 20 weeks | Outcome measurement: Mean serum 25(OH)D levels after 20 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive: 25(OH)D3 serum steady state reached? | Assessment if 25(OH)D3 serum levels will reach a steady state after 24 weeks supplementation of 3 doses of Hy.D and 1 dose of vitamin D3 | 0, 4, 8, 12, 16, 20, 24 weeks after study start |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisette De Groot, Prof | Wageningen University | Principal Investigator |
| Michael Tieland, PhD | Wageningen University | Principal Investigator |
| Luc van Loon, Prof | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University | Wageningen | Wageningen | 6700 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28433267 | Derived | Vaes AMM, Tieland M, de Regt MF, Wittwer J, van Loon LJC, de Groot LCPGM. Dose-response effects of supplementation with calcifediol on serum 25-hydroxyvitamin D status and its metabolites: A randomized controlled trial in older adults. Clin Nutr. 2018 Jun;37(3):808-814. doi: 10.1016/j.clnu.2017.03.029. Epub 2017 Mar 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 10 µg/day Hy.D Calcifediol | Dietary Supplement | 10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks |
|
| 15 µg/day Hy.D Calcifediol | Dietary Supplement | 15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks |
|
| 20 µg/day vitamin D3 | Dietary Supplement | 20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks |
|
| 20 weeks after initial compound intake |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks | Outcome measurement: Mean serum 25(OH)D levels after 24 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. | 24 weeks after initial compound intake |
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
Not provided
Not provided