Comparison of Serum 25-Hydroxyvitamin D Levels After A Single Oral Dose of Vitamin D3 Formulations in Mild Vitamin D3 Deficiency

ABSTRACT

Objective:To compare the levels of serum 25 Hydroxyvitamin D levels after a single large oral dose (60,000 IU) of different vitamin D3 formulations. Materials and Methods: Ninety?one volunteers with mild vitamin D deficiency (18–29 ng/ml) were selected and randomly assigned to three parallel groups. Groups-I received liquid, Group-II received sachet, and Group-III received tablet formulation of cholecalciferol as a single dose of 60,000 IU orally after 8–10 h of overnight fasting. Serum 25(OH) D concentrations were measured at baseline, 24 h, 7 days, and 14 days after drug administration. Various hematology and biochemical parameters were also assessed for baseline safety evaluation. Results: Baseline serum 25(OH) D concentrations in Groups I (liquid), II (sachet), and III (tablet) was 24.75 ± 4.77 ng/mL, 23.25 ± 4.15 ng/mL, and 23.18 ± 5.52 ng/mL, respectively. After supplemented with three formulations, only tablet group after 24 h showed increase in serum 25-OH-D concentration of 8.07 units from its baseline. Whereas after 7th day, no significant difference in absorption was observed but after 14 th day, all three groups showed increase in serum 25-OH-D concentration, in which tablet group (50.10 ± 94.99 ng/ml) showed highest increase in absorption (26.92 units) from their baseline values. During intergroup comparison between three formulations at the time of investigation, only liquid group after 24 h showed increased serum concentration by P values (0.03, 0.02) as compared to sachet and tablet group. However, After 7th and 14th day, there was no statistically difference was observed between three groups. Conclusion: Single oral dose of 60,000 IU dose of vitamin D liquid formulation has higher absorption value as after 24 h and tablet formulation showed higher absorption after 7th days. In emergency paucity of vitamin D, these observations findings can have critical conclusions to state the suitable dietary formulation of vitamin D.