Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial

PLoS One. 2014 Aug 28;9(8):e102965. doi: 10.1371/journal.pone.0102965. eCollection 2014.

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-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 25(OH)vitamin D and 1,25(OH)2vitamin 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 25(OH)vitamin D and 1,25(OH)2vitamin 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Calcium / urine*
  • Cholecalciferol / pharmacology*
  • Double-Blind Method
  • Female
  • Fibroblast Growth Factor-23
  • Fibroblast Growth Factors / blood
  • Healthy Volunteers
  • Humans
  • Male
  • Middle Aged
  • Vitamin D / analogs & derivatives*
  • Vitamin D / blood
  • Vitamins / pharmacology*

Substances

  • FGF23 protein, human
  • Vitamins
  • Vitamin D
  • Cholecalciferol
  • Fibroblast Growth Factors
  • 1,25-dihydroxyvitamin D
  • Fibroblast Growth Factor-23
  • 25-hydroxyvitamin D
  • Calcium

Associated data

  • ClinicalTrials.gov/NCT00952562

Grants and funding

The work was supported by The Danish Society of Nephrology and Region Zealand Health Sciences Research Foundation. The study medication was kindly delivered by D3Pharmacy, Denmark. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.