Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial
José Luis Pérez-Castrillón MD, PhD, Antonio Dueñas-Laita MD, PhD, Maria Luisa Brandi MD, PhD, Esteban Jódar MD, PhD, Javier del Pino-Montes MD, PhD
Journal of Bone and Mineral Research - 08 June 2021 https://doi.org/10.1002/jbmr.4387
Each month the researchers gave the supplement THEN made the blood measurement
personal communication with the corresponding author
The blood response to Calcifediol is far faster than that due to Vitamin D,
so it is possible that Calcifediol response could be seen in the blood test
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 one-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(OH)D levels above 30 ng/mL after 4 months. 303 patients were enrolled, of whom 298 were included in the 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 25000 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 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.
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