Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial
J Bone Miner Res. 2021 Jun 8. doi: 10.1002/jbmr.4387
José Luis Pérez-Castrillón 1 2, Antonio Dueñas-Laita 2 3, Maria Luisa Brandi 4, Esteban Jódar 5 6, Javier Del Pino-Montes 7 8, José Manuel Quesada-Gómez 9 10, Fernando Cereto Castro 11, Carlos Gómez-Alonso 12, Laura Gallego López 13, José Manuel Olmos Martínez 14 15, María Rosa Alhambra Expósito 9 16, Bernat Galarraga 17, Jesús González-Macías 15 18, Roger Bouillon 19, Gonzalo Hernández-Herrero 20, Nieves Fernández-Hernando 20, Paula Arranz-Gutiérrez 20, Sandra P Chinchilla 20
Neither group got to 30 ng/ml in 4 months with monthly dosing
This study gave the Vitamin D group only 25,000 IU per month
Many studies give 50,000 IU/week (8X as miuch)
This study reports on the first 4 months of the trial.
The last 12 months will hopefully be reported on soon
It is not clear that Calcidiol (Calcifediol) is significantly better than regular Vitamin D
- Calcidiol costs about 70X more per IU than vitamin D
- Calcidiol requires a prescription, whereas normal vitamin D is over-the counter
- Have been unable to get independant confirmation that Calcidiol has a fast response time
- There is vastly more information for Vitamin D concerning
- loading doses, co-factors, time between doses, etc.
- This study was written by the company making it
Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions. Furthermore, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, despite being the direct precursor of calcitriol and the biomarker of vitamin D status. This 1-year, phase III-IV, double-blind, randomized, controlled, multicenter clinical trial assessed the efficacy and safety of calcifediol 0.266 mg soft capsules in vitamin D-deficient postmenopausal women, compared to cholecalciferol. Results reported here are from a prespecified interim analysis, for the evaluation of the study's primary endpoint: the percentage of patients with serum 25-hydroxyvitamin D (25(OH)D) levels above 30 ng/ml after 4 months. A total of 303 patients were enrolled, of whom 298 were included in the intention-to-treat (ITT) population. Patients with baseline levels of serum 25(OH)D <20 ng/ml were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months, calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months, and cholecalciferol 25,000 IU/month for 12 months. At month 4, 35.0% of postmenopausal women treated with calcifediol and 8.2% of those treated with cholecalciferol reached serum 25(OH)D levels above 30 ng/ml (p < 0.0001). The most remarkable difference between both drugs in terms of mean change in serum 25(OH)D levels was observed after the first month of treatment (mean ± standard deviation change = 9.7 ± 6.7 and 5.1 ± 3.5 ng/ml in patients treated with calcifediol and cholecalciferol, respectively). No relevant treatment-related safety issues were reported in any of the groups studied. These results thus confirm that calcifediol is effective, faster, and more potent than cholecalciferol in raising serum 25(OH)D levels and is a valuable option for the treatment of vitamin D deficiency.