Resumen:
Background
Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions (such as immunomodulation). In this sense, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, its optimal dosing and treatment duration, despite being the direct precursor of calcitriol and the biomarker of vitamin D status.
Objectives
To assess the efficacy and safety of long-term treatment with calcifediol soft capsules compared to cholecalciferol (vitamin D3) in vitamin D deficiency.
Methods
This was a Phase III-IV, double blind, randomised, controlled, multicentre clinical trial. Postmenopausal women with baseline levels of 25(OH)D < 20 ng/ml were randomised 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.
Results
303 patients were enrolled, and 298 were included in the ITT population. There were no significant differences in terms of demographic variables, and the mean basal 25(OH)D levels were 13.2 ± 3.7 ng/ml. After 4 months of treatment, 25(OH)D levels over 30 ng/m...