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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
59
5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
Wageningen University
Wageningen, Wageningen, Netherlands
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20 weeks after initial compound intake
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks
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20 µg/day vitamin D3 taken together with breakfast for a total period of 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.
Time frame: 24 weeks after initial compound intake
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
Time frame: 0, 4, 8, 12, 16, 20, 24 weeks after study start