Treatment of Vitamin D Deficiency with Calcifediol: Efficacy and Safety Profile and Predictability of Efficacy
Abstract
:1. Introduction
1.1. Methods
1.2. Short- and Long-Term Efficacy and Safety of Calcifediol
2. Short-Term Efficacy
3. Long-Term Efficacy
4. Safety of Calcifediol
5. Predictability of Calcifediol
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Authors | Type of Study | Population | Design | Baseline Vitamin D ng/L/nmol/L | Methods Vitamin D | Superiority of Calcifediol | Other Data |
---|---|---|---|---|---|---|---|
Russo et al. [12] | Open | 18 pre- and postmenopausal females | One arm with 500 μg of 25D3. 16 weeks | 18.1 ± 12.5 ng/mL 45.1 ± 31.1 nmol/L | RIA | NA | 88% > 30 ng/mL (74.8 nmol/L) |
Minisola et al. [8] | RCT | 87 postmenopausal females | Three arms of 25D3 20μg/day,40μg/day,125μg/week. 16 weeks | 16.5 ± 7.5 ng/mL 41.1 ± 18.7 nmol/L | Chemiluminiscence | NA | 100% > 30 ng/mL (74.8 nmol/L) |
Cashman et al. [13] | RCT | 56 adults (25m, 31f) > 50 years | Three arms of 20μg/day D3, 7μg/day and 20μg/day 25D3. 10 weeks | 17.4 ± 4.9 ng/mL 43.6 ± 122.3 nmol/L | ELISA | YES | >Dose 20μg/day 25D3 |
Bischoff-Ferrari et al. [14] | RCT | 20 postmenopausal females | Two arms, 20μg/day D3 vs20μg/day 25D3. 16 weeks | 13 ± 3.8 ng/mL 32.4 ± 9.4 nmol/L | HPLC-MS/MS | YES | - |
Jetter et al. [11] | RCT | 35 females aged 50–70 years | 7 arms:20μg/day and 140μg/week of D3 vs 20μg/day and 140 μg/week of 25D3 and combination of both arms. 15 weeks | 13 ± 5 ng/mL 32.4 ± 12.4 nmol/L | HPLC-MS/MS | YES | Long-term kinetics similar between the two supplements |
Shieh et al. [15] | RCT | 35 subjects aged >18 years | Two arms 60μg/day of D3 vs 20μg/day of 25D3. 16 weeks | <20ng/ml | HPLC-MS/MS | YES | Determination of free vitamin D with superiority of calcifediol |
Perez-Castrillón et al. [16] | RCT | 303 postmenopausal females | Two arms 625μg/month D3 vs 266μg/month 25D3. 16 weeks | 13 ± 3.9 ng/mL 32.4 ± 9.7 nmol/L | Chemiluminiscence | YES | Greater efficacy at one month and four months for both total vitamin D and free vitamin D |
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 |
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Pérez-Castrillon, J.-L.; Usategui-Martín, R.; Pludowski, P. Treatment of Vitamin D Deficiency with Calcifediol: Efficacy and Safety Profile and Predictability of Efficacy. Nutrients 2022, 14, 1943. https://doi.org/10.3390/nu14091943
Pérez-Castrillon J-L, Usategui-Martín R, Pludowski P. Treatment of Vitamin D Deficiency with Calcifediol: Efficacy and Safety Profile and Predictability of Efficacy. Nutrients. 2022; 14(9):1943. https://doi.org/10.3390/nu14091943
Chicago/Turabian StylePérez-Castrillon, Jose-Luis, Ricardo Usategui-Martín, and Pawel Pludowski. 2022. "Treatment of Vitamin D Deficiency with Calcifediol: Efficacy and Safety Profile and Predictability of Efficacy" Nutrients 14, no. 9: 1943. https://doi.org/10.3390/nu14091943