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.

Both calcifediol and cholecalciferol supplementation produced significant increases in serum 25(OH)D over 6 months.

• Serum 25(OH)D increased by 355% in the cholecalciferol group and 574% in the calcifediol group (p < 0.001 for both).
• The calcifediol group received 25 µg daily capsules; the cholecalciferol group received 100 µg (4000 IU) daily sachets.
• 46 participants from the calcifediol group and 37 from the cholecalciferol group completed the 6-month follow-up.
• Study was conducted in apparently healthy individuals with vitamin D deficiency in Chandigarh, India (latitude 30.7° North, 76.8° East).

Both supplementation groups showed significant increases in serum 1,25(OH)2D and significant decreases in iPTH and ALP.

• Serum 1,25(OH)2D increased significantly in both groups (p < 0.001).
• iPTH decreased significantly in both groups (p < 0.001).
• ALP decreased significantly in both groups (p = 0.016).
• These findings were observed across the 6-month intervention period.

Serum ALP decreased significantly more in the calcifediol group than in the cholecalciferol group.

• The difference in ALP reduction between groups was statistically significant.
• No appreciable difference in other biochemical parameters was noted between the two groups.
• This was the only between-group difference in biochemical outcomes identified.

No episodes of hypercalcaemia or new renal stone disease were observed in either group during follow-up.

• Safety was monitored over 6 months in both treatment groups.
• No hypercalcaemia occurred in any participant in either the calcifediol (n=46) or cholecalciferol (n=37) completers.
• No incident renal stone disease was detected during follow-up.
• These findings support the safety profile of both supplementation regimens.

Hypercalciuria was observed in a subset of participants in both groups with no significant difference between groups.

• Hypercalciuria was defined as spot urine calcium-to-creatinine ratio > 0.2 mg/mg.
• Hypercalciuria was detected in 8 of 46 individuals (approximately 17%) in the calcifediol group at the final visit.
• Hypercalciuria was detected in 5 of 37 individuals (approximately 14%) in the cholecalciferol group at the final visit.
• There was no significant difference in hypercalciuria incidence between the two groups.

The study enrolled 70 subjects initially screened per group, with differential retention rates between the two supplementation groups.

• Following initial screening of 70 subjects in each group, 62 were included in the calcifediol group and 41 in the cholecalciferol group.
• 46 from the calcifediol group and 37 from the cholecalciferol group completed the 6-month follow-up.
• The study design was prospective and open-label interventional.