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.

May 19, 2021The American journal of clinical nutrition

A trial to evaluate how well the body absorbs oral 25-hydroxyvitamin D3 and vitamin D3 in healthy adults with different body weights and those with intestinal malabsorption.

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Abstract

Malabsorptive patients exhibited 64% lower absorption of vitamin D3 compared to healthy participants.

Oral vitamin D3 supplementation resulted in a significantly lower absorption rate in malabsorptive patients.
AUC (area under the curve) for vitamin D3 in malabsorptive patients was 1177 ± 425 ng · h/mL, while it was 3258 ± 496 ng · h/mL in healthy participants.
No significant difference in absorption of 25-hydroxyvitamin D3 was found between malabsorptive and healthy participants.
Higher BMI was associated with a 53% lower absorption of vitamin D3 in healthy participants.
AUC for the higher BMI group was 2089 ± 490 ng · h/mL compared to 4427 ± 313 ng · h/mL for the lower BMI group.

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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 D3 [25(OH)D3] and oral vitamin D3 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 µg of either vitamin D3 or 25(OH)D3 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)D3 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 µg vitamin D3 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 µg 25(OH)D3 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 µg vitamin D3 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 µg 25(OH)D3 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. This trial was registered at clinicaltrials.gov as (NCT03401541.

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Abstract

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