Efficacy, safety, and dose-response effects of calcifediol supplementation on 25-hydroxyvitamin D, parathyroid hormone, and 1,25-dihydroxyvitamin D levels in healthy adults: An open-label, interventional pilot study.

Nov 6, 2023Indian journal of pharmacology

Calcifediol supplementation may affect vitamin D and hormone levels in healthy adults.

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Abstract

97.1% of participants in the 50 μg-group and 93.1% in the 25 μg-group achieved sufficient serum 25-hydroxyvitamin D levels after supplementation.

Both dosage groups experienced significant increases in serum 25-hydroxyvitamin D levels, with means of 84.0 ± 27.7 ng/ml in the 50 μg-group and 58.0 ± 23.6 ng/ml in the 25 μg-group at 4 weeks.
At 8 weeks, serum 25-hydroxyvitamin D levels further increased to 94.3 ± 21.8 ng/ml in the 50 μg-group and 76.0 ± 16.4 ng/ml in the 25 μg-group.
Parathyroid hormone levels decreased significantly in both groups at 4 and 8 weeks.
Levels of 1,25-dihydroxyvitamin D rose significantly in both groups over the study period.
No cases of hypercalcemia or symptomatic kidney stones were reported during the trial.

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BACKGROUND: Vitamin D deficiency (VDD) is highly prevalent across the globe. Cholecalciferol (Vitamin D3) fails to attain sufficient serum concentrations of 25-hydroxyvitamin D (25(OH)D) in a significant proportion of supplemented individuals. Calcifediol (25-hydroxyvitamin D3) is less studied in healthy adults and its effects on 25(OH)D, parathyroid hormone (PTH), and 1,25-dihydroxyvitamin D (1,25(OH)2D) at higher doses are not well known.

MATERIALS AND METHODS: The study was an open-label, interventional trial recruiting consecutive participants with VDD who were allocated to receive either 2 capsules (50 μg-group) or 1 capsule (25 μg-group) daily doses of calcifediol. Baseline assessment included clinicodemographic parameters, dietary calcium, calcemic (calcium, inorganic phosphate, albumin, alkaline phosphatase, urine spot calcium/creatinine), and hormonal parameters (25(OH)D, PTH, and 1,25(OH)2D). Participants were followed up at 4 and 8 weeks with repeat assessments of calcemic and hormonal parameters.

RESULTS: There were 64 participants, 35 (50 μg-group) and 29 (25 μg-group), without any significant difference in any of the baseline parameters. 97.1% participants in the 50 μg-group (at 4 and 8 weeks) and 93.1% (at 4 weeks) and 96.5% (at 8 weeks) in the 25 μg-group attained 25(OH)D sufficiency (≥30 ng/ml) with calcifediol. The mean serum 25(OH)D was 84.0 ± 27.7 ng/ml in the 50 μg-group and 58.0 ± 23.6 ng/ml in the 25 μg-group group at 4 weeks, which later rose to 94.3 ± 21.8 ng/ml and 76.0 ± 16.4 ng/ml, respectively, at 8 weeks. PTH levels decreased in both groups at both time points. 1,25(OH)2D rose significantly in both groups at 4 and 8 weeks but was not significantly different between both groups. There was no case of incident hypercalcemia or symptomatic nephrolithiasis.

CONCLUSION: Calcifediol is a safe and efficacious alternative for oral Vitamin D supplementation in young adults. Increment in 25(OH)D levels is rapid and dose-dependent.

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Efficacy, safety, and dose-response effects of calcifediol supplementation on 25-hydroxyvitamin D, parathyroid hormone, and 1,25-dihydroxyvitamin D levels in healthy adults: An open-label, interventional pilot study.

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