Effects of High Doses of Cholecalciferol in Normal Subjects: A Randomized Double-Blinded, Placebo-Controlled TrialReportar como inadecuado




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Background

Vitamin D repletion with high doses of vitamin D is often recommended to patients and healthy subjects. The safety, especially concerning changes in urinary calcium excretion is of great importance.

Methods

In a double-blinded, placebo-controlled study in 40 healthy volunteers, we examined the changes in mineral metabolism during supplementation with 3000 IU of oral cholecalciferol daily during 4 months.

Results

Both 25OHvitamin D and 1,25OH2vitamin D increased significantly in the active treated group as compared to the placebo group 186% versus 14% P<0.001 and 28% versus – 8% P<0.001. No change was observed in urinary calcium excretion in the active group compared to the placebo group P = 0.891. Fibroblast growth factor 23 increased significantly by 10% P<0.018 in the active group. However, there was no difference in changes in FGF23 between treatment groups P = 0.457.

Conclusion

High dose cholecalciferol significantly increases 25OHvitamin D and 1,25OH2vitamin D levels compared to placebo. No changes in urinary calcium excretion or other measured components of the mineral metabolism were found between groups.

Trial Registration

ClinicalTrials.gov NCT00952562.



Autor: Birgitte Nygaard , Niels Erik Frandsen, Lisbet Brandi, Knud Rasmussen, Ove Vyff Oestergaard, Lars Oedum, Hans Christian Hoeck, Di

Fuente: http://plos.srce.hr/



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