An open-label interventional study on efficacy and safety of 25 µg of daily calcifediol capsule versus 100 µg of cholecalciferol sachets in apparently healthy volunteers

Despite the multiple advantages of 25-hydroxyvitamin D (calcifediol or 25(OH)D) compared to cholecalciferol, it is used sparingly. This study was planned to assess the safety and efficacy of supplementing daily 25 µg of calcifediol capsules vis-a-vis 100 µg (4000 IU) of cholecalciferol sachets in apparently healthy individuals with vitamin D deficiency in Chandigarh, India (latitude 30.7° North, 76.8° East). It was a prospective, interventional study to evaluate the effects of calcifediol vis-a-vis cholecalciferol. Following initial screening of 70 subjects in each group, 62 were included in the calcifediol and 41 in the cholecalciferol group. Forty-six from calcifediol and 37 from cholecalciferol group completed the 6-month follow up. There was a significant increase in serum 25(OH)D (355% in cholecalciferol & 574% in calcifediol groups, respectively, <i>p</i> < 0.001) and 1,25 (OH)₂D (<i>p</i> < 0.001) with a marked decrease in iPTH (<i>p</i> < 0.001) and ALP (<i>p</i> = 0.016) in both groups. Though serum ALP decreased significantly more in the calcifediol group than the cholecalciferol group, no appreciable difference in other biochemical parameters was noted between the groups. No episodes of hypercalcaemia or incidence of new renal stone disease were observed during follow-up. However, hypercalciuria (spot urine calcium creatinine > 0.2 mg/mg) was noted in 8/46 individuals in the calcifediol group and 5/37 individuals in the cholecalciferol group at final visit with no significant difference between two groups. This study establishes the efficacy and safety of correcting vitamin D deficiency with daily 25 µg calcifediol capsules as an alternative to 4000 IU (100 µg) cholecalciferol sachets.