A pilot-randomized, double-blind crossover trial to evaluate the pharmacokinetics of orally administered 25-hydroxyvitamin D3 and vitamin D3 in healthy adults with differing BMI and in adults with intestinal malabsorption

Background: Obese and malabsorptive patients have difficulty increasing serum 25-hydroxyvitamin D [25(OH)D] after taking vitamin D supplementation. Since 25(OH)D is more hydrophilic than vitamin D, we hypothesized that oral 25(OH)D supplementation is more effective in increasing serum 25(OH)D concentrations in these patients. Objectives: We aimed to investigate the pharmacokinetics of oral 25-hydroxyvitamin D-3 [25(OH)D-3] and oral vitamin D-3 in healthy participants with differing BMI and malabsorptive patients. Methods: A randomized, double-blind crossover trial was performed in 6 malabsorptive patients and 10 healthy participants who were given 900 mg of either vitamin D-3 or 25(OH)D-3 orally followed by a pharmacokinetic study (PKS). After >= 28 d from the first dosing, each participant returned to receive the other form of vitamin D and undergo another PKS. For each PKS, serum vitamin D3 and 25(OH)D-3 were measured at baseline and at 2, 4, 6, 8, and 12 h and days 1, 2, 3, 7, and 14. Pharmacokinetic parameters were calculated. Results: Data were expressed as means +/- SEMs. The PKS of 900 mu g vitamin D-3 revealed that malabsorptive patients had 64% lower AUC than healthy participants (1177 +/- 425 vs. 3258 +/- 496 ng . h/mL; P < 0.05). AUCs of 900 mg 25(OH)D-3 were not significantly different between the 2 groups (P = 0.540). The 10 healthy participants were ranked by BMI and categorized into higher/lower BMI groups (5/group). The PKS of 900 mg vitamin D-3 showed that the higher BMI group had 53% lower AUC than the lower BMI group (2089 +/- 490 vs. 4427 +/- 313 ng . h/mL; P < 0.05), whereas AUCs of 900 mg 25(OH)D-3 were not significantly different between the 2 groups (P = 0.500). Conclusions: Oral 25(OH)D3 may be a good choice for managing vitamin D deficiency in malabsorption and obesity.

Automated summary

The study aimed to investigate the pharmacokinetics of oral 25-hydroxyvitamin D-3 [25(OH)D-3] and oral vitamin D-3 in healthy participants with different BMI and malabsorptive patients. The results suggest that oral 25(OH)D3 may be a good choice for managing vitamin D deficiency in malabsorptive and obese patients.