Research paper
Effects of High Doses of Cholecalciferol in Normal Subjects: A Randomized Double-Blinded, Placebo-Controlled Trial
Study answer
What this study found
Cholecalciferol did not significantly change 24-hour urinary calcium excretion versus placebo, but it substantially increased circulating vitamin D metabolites. The primary endpoint, change in 24-hour urinary calcium excretion, showed no between-group difference (P = 0.891). In the active group, 25(OH) vitamin D increased 186% versus 14% in placebo (P < 0.001) and 1,25(OH)2 vitamin D increased 28% versus -8% in placebo (P < 0.001). FGF23 increased 10% in the cholecalciferol group (P = 0.018), but the between-group difference in FGF23 change was not significant (P = 0.457). The authors…
- Study & population
- Randomized, double-blind, placebo-controlled trial in healthy vitamin D-insufficient adults aged 18 years or older at Roskilde University Hospital in Denmark.
- Intervention
- The active arm received oral cholecalciferol 3000 IU daily, given as 3 tablets of vitamin D3, for 16 weeks.
- Key limitation
- Small sample size, with only 22 participants in the active arm and 16-week follow-up, limits precision and long-term interpretation.
View source
Open PDFOriginal abstract
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-con…