Table 2.
Long-term studies.
| Authors | Type of Study | Population | Design | Baseline Vitamin D ng/mL/nmol/L |
Methodology Vitamin D |
Superiority of Calcifediol | Other Data |
|---|---|---|---|---|---|---|---|
| Larrosa et al. [18] | Open | 70 subjects (11 males and 59 females | After loading dose (1064 μg 25-D3 in 1 month) Three arms: 266 μg /month,266 μg /3 weeks,266μg /2 weeks. 28 ± 14 months | 17.6 ± 6ng/mL 43.9 ± 14.9 nmol/L |
RIA | NA | 78%, 89%, 93% > 30 ng/mL (74.8 nmol/L) 4%, 11%, 19% > 95 ng/mL (237.1 nmol/L) |
| Larrosa et al. [19] | Open | 129 subjects (109 females, 20 males) | After loading dose (1064 μg 25-D3 in 1 month) Two arms: 20 μg/day D3 vs 266 μg/3 weeks. 12 months | 16 ± 5 ng/mL 39.9 ± 12.4 nmol/L |
RIA | YES | |
| Rossini et al. [20] | RCT | 271 females | Two arms 21 μg/day D3 vs 100 μg/week. 12 months | 22 ± 6 ng/mL 54.9 ± 14.9 nmol/L |
RIA | NO | |
| Navarro-Valverde et al. [21] | RCT | 40 postmenopausal females | 4 arms:20 μg/day D3 vs20 μg/day, 266 μg/week,266 μg/2 weeks 25-D3. 12 months | 15.5 ± 1.7 ng/mL 38.7 ± 4.2 nmol/L |
HPLC | YES | Dose dependent effect |
| Ruggero et al. [22] | RCT | 67 subjects (42 females and 25 males) | Two arms: 20 μg/day D3 vs 20 μg/day 25-D3. 7 months | 10 (4-16) ng/mL 24.9 (9.9-39.9) nmol/L |
RIA | NO | Initial differences but no differences at 210 days |
| Graeff-Armas et al. [25] | RCT | 91 subjects (53 females and 38 males) | Four arms: 20 μg/day D3 vs 10 μg /day,15 μg/day,20 μg/day 25-D3. 6 months | 19.2 ± 6.8 ng/mL 48 ± 17 nmol/L |
HPLC-MS/MS | YES | Dose dependent effect. Suppression of the supplement reduced vitamin D levels to baseline |
| Corrado et al. [27] | RCT | 160 postmenopausal females | Four arms: 7500 μg single dose, 2500 μg/2 months, 175 μg/week D3 vs 116μg/week 25-D3. 6 months | 13.4 ± 4.3 ng/mL 33.4 ± 10.7 nmol/L |
Chemiluminescence | YES | Dose dependent effect |
| Jodar E et al. [26] | RCT | 303 postmenopausal females | Two arms 625 μg/month D3 vs 266 μg/month 25D3. 12 months | 13 ± 3.9 ng/mL 32.4 ± 9.7 nmol/L |
Chemiluminescence | YES | |
| Gonnelli et al. [28] | RCT | 50 osteopenic or osteoporotic females | Two arms, 20 μg/day, 30 μg/day No control with cholecalciferol 6 months |
15.6 ± 4.8 ng/mL 39.4 ± 11.9 nmol/L |
Chemiluminescence | NA | 90 days: 59.3 ng/mL (148 nmol/L) dose 20 μg/day 60 days: 72.3 ng/mL (180.4 nmol/L) dose 30 μg/day |
RIA: Radioimmunoassay; HPLC: Liquid chromatography; HPLC-MS/MS: Liquid chromatography coupled to tandem mass spectrometry detection.